A study to evaluate the food effect on drug availability, pharmacokinetic (PK) properties, safety and tolerability of two different dose combination therapy of saxagliptin/dapagliflozin/metformin extended-release (XR) against individual component co-administration.

Study identifier:D168AC00001

ClinicalTrials.gov identifier:NCT03169959

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomised, 3-Period, 3-Treatment, Single-dose, Open-label, Single-center, Crossover Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin / 10 mg Dapagliflozin / 1000 mg Metformin XR Relative to Individual Components (Onglyza® and XIGDUO® XR) Co-administered to Healthy Subjects

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

2.5 mg Saxagliptin tablet, 5 mg dapagliflozin / 1000 mg metformin XR tablet, Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR, 5 mg saxagliptin, 10 mg dapagliflozin / 1000 mg metformin XR tablet, Triple FCDP - 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 29 May 2017

Primary Completion Date: 03 Aug 2017

Study Completion Date: 03 Aug 2017

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2018 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

1. Provision of signed and dated, written informed consent prior to any study specific procedures.
2. Healthy male and/or female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
3. Female subject must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) at Screening and negative urine pregnancy test within 24 hours prior to investigational medicinal product (IMP) administration and either: a) Be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: - Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
b). Or, if of childbearing potential: - Must not be nursing (breastfeeding). -And, if heterosexually active, agree to consistently use an acceptable method of contraception to avoid pregnancy, from at least 4 weeks prior to dosing and throughout the study and for up to 90 days after the last dose of IMP.
4. Sexually active fertile male subjects must use effective birth control for the entire study and 90 days after the last dose of IMP if their partners are women of childbearing potential.
5. Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.

Exclusion Criteria

1.History of any clinically significant disease or disorder which, in the opinion of the principal investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer’s ability to participate in the study.
2. Current or recent (within 3 months of first IMP dosing) gastrointestinal (GI) disease that may impact drug absorption and affect the PK of the study drugs. Additionally, any GI surgery (e.g., partial gastrectomy, pyloroplasty) including cholecystectomy that may impact drug absorption.
3. Any major surgery, as determined by the investigator, within 4 weeks of first IMP dosing.
4. Donation of > 400 mL of blood within 8 weeks or donation of plasma (except at the Screening Visit) within 4 weeks of first IMP dosing.
5. Blood transfusion within 4 weeks of first IMP dosing.
6. Inability to tolerate oral medication.
7. Inability to tolerate venipuncture or inadequate venous access as determined by the investigator.
8. Recent (within 6 months of first IMP dosing) drug or alcohol abuse as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), Diagnostic Criteria for Drug and Alcohol Abuse.
9. Subjects who drink more than 3 cups of coffee or other caffeine-containing products a day, or 5 cups of tea a day.
10. Use of tobacco-containing or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to first check-in (Day -1, Treatment Period 1), or a positive nicotine test (i.e., cotinine) at Screening and/or check-in.
11. History of diabetes mellitus, heart failure, chronic or recurrent urinary tract infection (defined as 3 occurrences per year) and severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to saxagliptin, dapagliflozin and metformin.
14. Recent vulvovaginal mycotic infection (within 2 months prior to first IMP dosing).
15. Any other sound medical, psychiatric and/or social reason as determined by the investigator.
16. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of Screening.
17. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
18. Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest.
19. Positive screen for drugs of abuse or cotinine at Screening or on each admission to the clinical unit or positive screen for alcohol on each admission to the clinical unit.
20. Use of saxagliptin, dapagliflozin and/or metformin within 3 months prior to the first administration of IMP.
21. Use of any prescription drugs or over the counter acid controllers within 4 weeks prior to the first administration of IMP except medication cleared by the medical monitor.
22. Use of drugs with enzyme-inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP.
23. Use of any prescribed or non-prescribed medication including analgesics (other than paracetamol / acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life. Note: Hormonal replacement therapy is not allowed.
24. Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
25. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

This study will be randomized, 3-period, 3-treatment, single-dose, open-label, single-center, crossover to assess the fed-state bioequivalence of a two triple Fixed-combination Drug Product (FCDP) of saxagliptin/dapagliflozin/metformin extended-release (XR) relative to individual components co-administered in approximately 84 healthy adult subjects. Eligible subjects will be healthy male and female aged 18 to 55 years, with a body weight of 50 to 100 kg and body mass index (BMI) of 18 to 32 kg/m2. Of the 84 randomized subjects (2 cohorts of 42 subjects each [3 treatments in each cohort]), at least 72 subjects (36 in each cohort) should be evaluable. Each randomized subject will receive 3 single-dose treatments and each treatment will be administered within 1 of the 3 successive treatment periods. Within each cohort subjects will be randomized to 1 to 6 treatment sequences prescribing the ordered sequence of 3 administered treatments with 7 subjects in each treatment sequence. The investigational medicinal product (IMPs) will be administered orally at single-dose to subjects within 5 minutes after standard meal (light-fat, low-calorie) in the morning (fed condition) or following a 10 hour fast (fasted condition). In both cohorts, test product will be compared with treatments of fed and fasted conditions Subjects in Cohort 1 will be randomized to one of the treatment sequences (ABC), (ACB), (BAC), (BCA), (CAB) or (CBA). Treatment A (Reference Product under fed conditions) - Single-dose of 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg metformin XR (XIGDUO XR) tablets. Treatment B (Test Product under fed conditions) - Single-dose of triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR. Treatment C (Test Product fasted conditions) - Single-dose of triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR. Subjects in Cohort 2 will be randomized to one of the treatment sequences (DEF), (DFE), (EDF), (EFD), (FDE) or (FED). Treatment D (Reference product under fed conditions) - Single-dose of 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg metformin XR (XIGDUO XR) tablet. Treatment E (Test Product under fed conditions) - Single-dose of triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR. Treatment F (Test Product under fasted conditions) - Single-dose of triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR. The study will comprise: - A screening period of maximum 28 days; - Three resident treatment periods - Day before dosing with the IMP (Day -1) until at least 72 hours after dosing; and will be discharged on the morning of Day 4; and - A follow-up visit within 5 to 7 days after the last dose of IMP. Treatment periods will be separated by a minimum washout period of 7 to 14 days between each IMP dose. The duration of the study will be approximately 7 to 9 weeks.

Location

Research Site

Baltimore, MD, United States, 21225

Arms	Assigned Interventions
Experimental: Cohort 1: Sequence 1 (ABC) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 2.5 mg Saxagliptin tablet A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with Type 2 diabetes mellitus (T2DM). Other Name: 2.5 mg ONGLYZA Drug: 5 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of sodium-glucose co-transporter 2 (SGLT-2), reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 5 / 1000 mg XIGDUO XR Drug: Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: Cohort 1: Sequence 2 (ACB) Subjects were randomized to treatment sequence 1 ACB: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 2.5 mg Saxagliptin tablet A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with Type 2 diabetes mellitus (T2DM). Other Name: 2.5 mg ONGLYZA Drug: 5 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of sodium-glucose co-transporter 2 (SGLT-2), reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 5 / 1000 mg XIGDUO XR Drug: Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: Cohort 1: Sequence 3 (BAC) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 2.5 mg Saxagliptin tablet A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with Type 2 diabetes mellitus (T2DM). Other Name: 2.5 mg ONGLYZA Drug: 5 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of sodium-glucose co-transporter 2 (SGLT-2), reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 5 / 1000 mg XIGDUO XR Drug: Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: Cohort 1: Sequence 4 (BCA) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 2.5 mg Saxagliptin tablet A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with Type 2 diabetes mellitus (T2DM). Other Name: 2.5 mg ONGLYZA Drug: 5 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of sodium-glucose co-transporter 2 (SGLT-2), reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 5 / 1000 mg XIGDUO XR Drug: Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: Cohort 1: Sequence 5 (CAB) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 2.5 mg Saxagliptin tablet A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with Type 2 diabetes mellitus (T2DM). Other Name: 2.5 mg ONGLYZA Drug: 5 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of sodium-glucose co-transporter 2 (SGLT-2), reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 5 / 1000 mg XIGDUO XR Drug: Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: Cohort 1: Sequence 6 (CBA) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5mg saxagliptin / 5mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 2.5 mg Saxagliptin tablet A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with Type 2 diabetes mellitus (T2DM). Other Name: 2.5 mg ONGLYZA Drug: 5 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of sodium-glucose co-transporter 2 (SGLT-2), reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 5 / 1000 mg XIGDUO XR Drug: Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: Cohort 2: Sequence 1 (DEF) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= Reference product - 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Test product - Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 5 mg saxagliptin A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Other Name: 5 mg ONGLYZA Drug: 10 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 10/1000 mg XIGDUO XR Drug: Triple FCDP - 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: Cohort 2: Sequence 2 (DFE) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= Reference product - 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Test product - Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 5 mg saxagliptin A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Other Name: 5 mg ONGLYZA Drug: 10 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 10/1000 mg XIGDUO XR Drug: Triple FCDP - 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: Cohort 2: Sequence 3 (EDF) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 5 mg saxagliptin A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Other Name: 5 mg ONGLYZA Drug: 10 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 10/1000 mg XIGDUO XR Drug: Triple FCDP - 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: Cohort 2: Sequence 4 (EFD) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= Reference product - 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Test product - Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 5 mg saxagliptin A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Other Name: 5 mg ONGLYZA Drug: 10 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 10/1000 mg XIGDUO XR Drug: Triple FCDP - 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: Cohort 2: Sequence 5 (FDE) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= Reference product - 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Test product - Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 5 mg saxagliptin A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Other Name: 5 mg ONGLYZA Drug: 10 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 10/1000 mg XIGDUO XR Drug: Triple FCDP - 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Experimental: COhort 2: Sequence 6 (FED) Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= Reference product - 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Test product - Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.	Drug: 5 mg saxagliptin A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Other Name: 5 mg ONGLYZA Drug: 10 mg dapagliflozin / 1000 mg metformin XR tablet Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Other Name: 10/1000 mg XIGDUO XR Drug: Triple FCDP - 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted on 84 (2 cohorts of 42 participants each [3 treatments per cohort]) healthy adult participants in a single center: PAREXEL Early Phase Clinical Unit, United States of America. In each cohort, participants were randomized to 1 of 6 treatment sequences (7 participants per sequence) and received 3 single-dose treatments.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening (maximum 28 days): informed consent form was signed; inclusion/exclusion, medical history, demographics, blood pressure, pulse, 12-Lead electrocardiogram, physical checkup, body weight, clinical laboratory tests, serum tests (follicular stimulating hormone [post menopausal women] & pregnancy) and urinary drug/alcohol screen were assessed.

Reporting Groups

	Description
Cohort 1: Treatment Sequence 1: ABC	Participants were randomized to receive single oral dose of treatment sequences ABC: A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin extended-release (XR) tablets (XIGDUO® XR) after food. B = Test product - Triple Fixed-combination drug product (FCDP) tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.
Cohort 1: Treatment Sequence 2: ACB	Participants were randomized to receive single oral dose of treatment sequences ACB: A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. B = Test product - Triple Fixed - FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food.
Cohort 1: Treatment Sequence 3: BAC	Participants were randomized to receive single oral dose of treatment sequences BAC: B = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.
Cohort 1: Treatment Sequence 4: BCA	Participants were randomized to receive single oral dose of treatment sequences BCA: B = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Cohort 1: Treatment Sequence 5: CAB	Participants were randomized to receive single oral dose of treatment sequences CAB: C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. B = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food.
Cohort 1: Treatment Sequence 6: CBA	Participants were randomized to receive single oral dose of treatment sequences CBA: C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. B = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Cohort 2: Treatment sequence 1: DEF	Participants were randomized to receive single oral dose of treatment sequences DEF: D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.
Cohort 2: Treatment sequence 2: DFE	Participants were randomized to receive single oral dose of treatment sequences DFE: D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food.
Cohort 2: Treatment sequence 2: EDF	Participants were randomized to receive single oral dose of treatment sequences EDF: E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.
Cohort 2: Treatment sequence 2: EFD	Participants were randomized to receive single oral dose of treatment sequences EFD: E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Cohort 2: Treatment sequence 2: FDE	Participants were randomized to receive single oral dose of treatment sequences FDE: F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food.
Cohort 2: Treatment sequence 2: FED	Participants were randomized to receive single oral dose of treatment sequences FED: F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.

Participant Flow: Overall Study

	Cohort 1: Treatment Sequence 1: ABC	Cohort 1: Treatment Sequence 2: ACB	Cohort 1: Treatment Sequence 3: BAC	Cohort 1: Treatment Sequence 4: BCA	Cohort 1: Treatment Sequence 5: CAB	Cohort 1: Treatment Sequence 6: CBA	Cohort 2: Treatment sequence 1: DEF	Cohort 2: Treatment sequence 2: DFE	Cohort 2: Treatment sequence 2: EDF	Cohort 2: Treatment sequence 2: EFD	Cohort 2: Treatment sequence 2: FDE	Cohort 2: Treatment sequence 2: FED
STARTED	7	7	7	7	7	7	7	7	7	7	7	7
COMPLETED	7	6	7	7	7	7	6	6	7	7	7	7
NOT COMPLETED	0	1	0	0	0	0	1	1	0	0	0	0
Low hemoglobin	0	0	0	0	0	0	0	1	0	0	0	0
Severe non-compliance to protocol	0	1	0	0	0	0	1	0	0	0	0	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The Randomized Set: Consisted of all participants randomized into the study.

Reporting Groups

	Description
Cohort 1: Treatment Sequence 1: ABC	Participants were randomized to receive single oral dose of treatment sequences ABC: A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin extended-release (XR) tablets (XIGDUO® XR) after food. B = Test product - Triple Fixed-combination drug product (FCDP) tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.
Cohort 1: Treatment Sequence 2: ACB	Participants were randomized to receive single oral dose of treatment sequences ACB: A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. B = Test product - Triple Fixed - FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food.
Cohort 1: Treatment Sequence 3: BAC	Participants were randomized to receive single oral dose of treatment sequences BAC: B = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.
Cohort 1: Treatment Sequence 4: BCA	Participants were randomized to receive single oral dose of treatment sequences BCA: B = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Cohort 1: Treatment Sequence 5: CAB	Participants were randomized to receive single oral dose of treatment sequences CAB: C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. B = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food.
Cohort 1: Treatment Sequence 6: CBA	Participants were randomized to receive single oral dose of treatment sequences CBA: C = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. B = Test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. A= Reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Cohort 2: Treatment sequence 1: DEF	Participants were randomized to receive single oral dose of treatment sequences DEF: D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.
Cohort 2: Treatment sequence 2: DFE	Participants were randomized to receive single oral dose of treatment sequences DFE: D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food.
Cohort 2: Treatment sequence 2: EDF	Participants were randomized to receive single oral dose of treatment sequences EDF: E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.
Cohort 2: Treatment sequence 2: EFD	Participants were randomized to receive single oral dose of treatment sequences EFD: E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Cohort 2: Treatment sequence 2: FDE	Participants were randomized to receive single oral dose of treatment sequences FDE: F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food. E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food.
Cohort 2: Treatment sequence 2: FED	Participants were randomized to receive single oral dose of treatment sequences FED: F = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. E = Test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. D= Reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.

Baseline Measures

	Cohort 1: Treatment Sequence 1: ABC	Cohort 1: Treatment Sequence 2: ACB	Cohort 1: Treatment Sequence 3: BAC	Cohort 1: Treatment Sequence 4: BCA	Cohort 1: Treatment Sequence 5: CAB	Cohort 1: Treatment Sequence 6: CBA	Cohort 2: Treatment sequence 1: DEF	Cohort 2: Treatment sequence 2: DFE	Cohort 2: Treatment sequence 2: EDF	Cohort 2: Treatment sequence 2: EFD	Cohort 2: Treatment sequence 2: FDE	Cohort 2: Treatment sequence 2: FED	Total
Number of Participants [units: Participants]	7	7	7	7	7	7	7	7	7	7	7	7	84
Age Continuous [units: Years] Mean ± Standard Deviation
Cohort 1	38.0 ± 10.9	35.6 ± 9.1	41.4 ± 10.2	40.7 ± 7.4	37.3 ± 11.7	35.9 ± 6.4	0 ± 0	0 ± 0	0 ± 0	0 ± 0	0 ± 0	0 ± 0	38.1 ± 9.2
Cohort 2	0 ± 0	0 ± 0	0 ± 0	0 ± 0	0 ± 0	0 ± 0	30.6 ± 11.0	33.0 ± 6.0	38.1 ± 9.4	39.6 ± 9.8	30.6 ± 10.5	31.6 ± 9.3	33.9 ± 9.6
Sex: Female, Male [units: Participants]
Female	3	2	3	2	3	2	2	1	3	2	3	3	29
Male	4	5	4	5	4	5	5	6	4	5	4	4	55
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0	0
Asian	0	0	0	0	1	0	1	0	0	0	0	0	2
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0	0
Black or African American	6	7	4	4	4	5	4	6	6	5	7	6	64
White	1	0	3	3	2	2	2	1	1	2	0	1	18
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0	0	0
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	0	1	3	2	3	4	0	1	1	0	0	0	15
Not Hispanic or Latino	7	6	4	5	4	3	7	6	6	7	7	7	69
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0	0	0

Outcome Measures

1. Primary Outcome Measure: Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1 [ Time Frame: Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours) ]

Measure Type	Primary
Measure Name	Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1
Measure Description	To evaluate bioequivalence by assessment of pharmacokinetics (PK) parameter AUC in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) in healthy volunteers.
Time Frame	Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Analysis Set: Participants who received at least 1 dose of study drug for whom at least 1 of the primary PK parameters could be calculated for at least 1 analyte (saxagliptin, 5-hydroxy saxagliptin, dapagliflozin or metformin) for 1 of the treatments within a Cohort and who had no major protocol deviations thought to impact on PK data analysis.

Reporting Groups

	Description
Treatment A	Randomized participants received single oral dose of reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment B	Randomized participants received single oral dose of test product - Triple Fixed - FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment C	Randomized participants received single oral dose of test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.

Measured Values

	Treatment A	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	41	41	41
Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1 [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Saxagliptin	51.53 (36.17%)	51.57 (35.47%)	46.90 (38.53%)
5-Hydroxy Saxagliptin	137.6 (36.72%)	136.1 (41.37%)	131.3 (38.87%)
Dapagliflozin	233.7 (23.52%)	239.9 (23.64%)	243.8 (24.77%)
Metformin	10980 (32.82%)	10930 (34.44%)	9511 (26.11%)

Statistical Analysis 1 for Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	100.19
90% Confidence Interval	( 87.89 to 114.22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	110.13
90% Confidence Interval	( 96.61 to 125.55 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	98.92
90% Confidence Interval	( 86.08 to 113.67 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	103.64
90% Confidence Interval	( 90.19 to 119.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	102.74
90% Confidence Interval	( 94.17 to 112.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	98.41
90% Confidence Interval	( 90.20 to 107.37 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	99.48
90% Confidence Interval	( 88.21 to 112.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Area under plasma concentration-time curve from time zero to infinity (AUC) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	114.96
90% Confidence Interval	( 102.26 to 129.24 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

2. Primary Outcome Measure: AUC - Cohort 2 [ Time Frame: Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours) ]

Measure Type	Primary
Measure Name	AUC - Cohort 2
Measure Description	To evaluate bioequivalence by assessment of PK parameter AUC in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers.
Time Frame	Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Analysis Set: Participants who received at least 1 dose of study drug for whom at least 1 of the primary PK parameters could be calculated for at least 1 analyte (saxagliptin, 5-hydroxy saxagliptin, dapagliflozin or metformin) for 1 of the treatments within a Cohort and who had no major protocol deviations thought to impact on PK data analysis.

Reporting Groups

	Description
Treatment D	Randomized participants received single oral dose of reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment E	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment F	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.

Measured Values

	Treatment D	Treatment E	Treatment F
Number of Participants Analyzed [units:participants]	41	40	41
AUC - Cohort 2 [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Saxagliptin	102.0 (26.25%)	102.6 (26.43%)	91.56 (26.29%)
5-Hydroxy Saxagliptin	321.2 (19.94%)	325.3 (19.84%)	318.7 (19.52%)
Dapagliflozin	472.5 (25.21%)	463.6 (22.38%)	487.5 (22.95%)
Metformin	11090 (31.77%)	10470 (30.82%)	9213 (26.97%)

Statistical Analysis 1 for AUC - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	100.64
90% Confidence Interval	( 91.41 to 110.79 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for AUC - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	112.08
90% Confidence Interval	( 101.81 to 123.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for AUC - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	101.32
90% Confidence Interval	( 94.22 to 108.96 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for AUC - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	102.04
90% Confidence Interval	( 94.90 to 109.73 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for AUC - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	98.19
90% Confidence Interval	( 90.09 to 107.02 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for AUC - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	95.08
90% Confidence Interval	( 87.24 to 103.63 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for AUC - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	94.53
90% Confidence Interval	( 84.55 to 105.70 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for AUC - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	113.61
90% Confidence Interval	( 101.53 to 127.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

3. Primary Outcome Measure: Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1 [ Time Frame: Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours) ]

Measure Type	Primary
Measure Name	Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1
Measure Description	To evaluate bioequivalence by assessment of PK parameter AUC(0-t) in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) in healthy volunteers.
Time Frame	Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Analysis Set: Participants who received at least 1 dose of study drug for whom at least 1 of the primary PK parameters could be calculated for at least 1 analyte (saxagliptin, 5-hydroxy saxagliptin, dapagliflozin or metformin) for 1 of the treatments within a Cohort and who had no major protocol deviations thought to impact on PK data analysis.

Reporting Groups

	Description
Treatment A	Randomized participants received single oral dose of reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment B	Randomized participants received single oral dose of test product - Triple Fixed - FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment C	Randomized participants received single oral dose of test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.

Measured Values

	Treatment A	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	41	41	41
Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1 [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Saxagliptin	49.86 (37.41%)	50.06 (36.08%)	45.32 (39.33%)
5-Hydroxy Saxagliptin	132.8 (37.96%)	131.0 (42.81%)	126.0 (40.38%)
Dapagliflozin	226.3 (24.21%)	232.5 (24.38%)	236.9 (25.31%)
Metformin	10910 (31.03%)	10780 (34.20%)	9265 (26.62%)

Statistical Analysis 1 for Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	100.51
90% Confidence Interval	( 87.91 to 114.93 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	110.62
90% Confidence Interval	( 96.75 to 126.49 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	98.65
90% Confidence Interval	( 85.45 to 113.88 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	103.97
90% Confidence Interval	( 90.06 to 120.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	102.80
90% Confidence Interval	( 94.00 to 112.42 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	98.14
90% Confidence Interval	( 89.74 to 107.32 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	98.89
90% Confidence Interval	( 88.51 to 110.49 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Area under the plasma concentration-curve from time zero to time of last quantifiable analyte concentration (AUC(0-t)) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	116.40
90% Confidence Interval	( 104.18 to 130.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

4. Primary Outcome Measure: AUC(0-t) - Cohort 2 [ Time Frame: Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours) ]

Measure Type	Primary
Measure Name	AUC(0-t) - Cohort 2
Measure Description	To evaluate bioequivalence by assessment of PK parameter AUC(0-t) in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers.
Time Frame	Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Analysis Set: Participants who received at least 1 dose of study drug for whom at least 1 of the primary PK parameters could be calculated for at least 1 analyte (saxagliptin, 5-hydroxy saxagliptin, dapagliflozin or metformin) for 1 of the treatments within a Cohort and who had no major protocol deviations thought to impact on PK data analysis.

Reporting Groups

	Description
Treatment D	Randomized participants received single oral dose of reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment E	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment F	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.

Measured Values

	Treatment D	Treatment E	Treatment F
Number of Participants Analyzed [units:participants]	41	40	41
AUC(0-t) - Cohort 2 [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Saxagliptin	100.2 (26.50%)	100.9 (26.70%)	89.95 (26.44%)
5-Hydroxy Saxagliptin	315.5 (20.14%)	319.6 (20.18%)	313.1 (19.77%)
Dapagliflozin	459.7 (24.05%)	452.4 (22.03%)	477.2 (22.72%)
Metformin	10910 (29.72%)	10420 (29.79%)	9248 (27.63%)

Statistical Analysis 1 for AUC(0-t) - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	100.73
90% Confidence Interval	( 91.43 to 110.98 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for AUC(0-t) - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	112.09
90% Confidence Interval	( 101.74 to 123.50 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for AUC(0-t) - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	101.34
90% Confidence Interval	( 94.15 to 109.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for AUC(0-t) - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	102.05
90% Confidence Interval	( 94.81 to 109.85 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for AUC(0-t) - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	98.44
90% Confidence Interval	( 90.52 to 107.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for AUC(0-t) - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	94.75
90% Confidence Interval	( 87.13 to 103.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for AUC(0-t) - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	95.66
90% Confidence Interval	( 86.16 to 106.20 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for AUC(0-t) - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	112.59
90% Confidence Interval	( 101.41 to 125.00 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

5. Primary Outcome Measure: Maximum observed plasma concentration (Cmax) - Cohort 1 [ Time Frame: Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours) ]

Measure Type	Primary
Measure Name	Maximum observed plasma concentration (Cmax) - Cohort 1
Measure Description	To evaluate bioequivalence by assessment of PK parameter Cmax in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) in healthy volunteers.
Time Frame	Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Analysis Set: Participants who received at least 1 dose of study drug for whom at least 1 of the primary PK parameters could be calculated for at least 1 analyte (saxagliptin, 5-hydroxy saxagliptin, dapagliflozin or metformin) for 1 of the treatments within a Cohort and who had no major protocol deviations thought to impact on PK data analysis.

Reporting Groups

	Description
Treatment A	Randomized participants received single oral dose of reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment B	Randomized participants received single oral dose of test product - Triple Fixed - FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment C	Randomized participants received single oral dose of test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.

Measured Values

	Treatment A	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	41	41	41
Maximum observed plasma concentration (Cmax) - Cohort 1 [units: ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Saxagliptin	10.61 (44.43%)	10.61 (37.47%)	11.69 (52.61%)
5-Hydroxy Saxagliptin	17.64 (46.59%)	17.29 (44.08%)	18.19 (43.81%)
Dapagliflozin	37.12 (30.81%)	42.31 (39.57%)	68.30 (30.05%)
Metformin	1041 (29.47%)	1098 (26.97%)	1195 (28.04%)

Statistical Analysis 1 for Maximum observed plasma concentration (Cmax) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	100.07
90% Confidence Interval	( 85.45 to 117.20 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Maximum observed plasma concentration (Cmax) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	90.61
90% Confidence Interval	( 77.37 to 106.12 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Maximum observed plasma concentration (Cmax) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	98.01
90% Confidence Interval	( 83.72 to 114.74 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Maximum observed plasma concentration (Cmax) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	94.92
90% Confidence Interval	( 81.08 to 111.12 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Maximum observed plasma concentration (Cmax) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	113.91
90% Confidence Interval	( 100.99 to 128.48 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Maximum observed plasma concentration (Cmax) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	61.81
90% Confidence Interval	( 54.80 to 69.72 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Maximum observed plasma concentration (Cmax) - Cohort 1

Groups^[1]	Treatment A, Treatment B
Other^[5]	105.45
90% Confidence Interval	( 95.24 to 116.76 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Maximum observed plasma concentration (Cmax) - Cohort 1

Groups^[1]	Treatment B, Treatment C
Other^[5]	91.79
90% Confidence Interval	( 82.90 to 101.63 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

6. Primary Outcome Measure: Cmax - Cohort 2 [ Time Frame: Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours) ]

Measure Type	Primary
Measure Name	Cmax - Cohort 2
Measure Description	To evaluate bioequivalence by assessment of PK parameter Cmax in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers.
Time Frame	Day 1 to Day 4 (At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Analysis Set: Participants who received at least 1 dose of study drug for whom at least 1 of the primary PK parameters could be calculated for at least 1 analyte (saxagliptin, 5-hydroxy saxagliptin, dapagliflozin or metformin) for 1 of the treatments within a Cohort and who had no major protocol deviations thought to impact on PK data analysis.

Reporting Groups

	Description
Treatment D	Randomized participants received single oral dose of reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment E	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment F	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.

Measured Values

	Treatment D	Treatment E	Treatment F
Number of Participants Analyzed [units:participants]	41	40	41
Cmax - Cohort 2 [units: ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Saxagliptin	22.30 (33.75%)	20.95 (26.90%)	24.80 (37.27%)
5-Hydroxy Saxagliptin	45.83 (19.51%)	46.38 (26.11%)	49.28 (26.72%)
Dapagliflozin	81.75 (36.82%)	75.70 (24.96%)	123.8 (27.33%)
Metformin	1104 (27.10%)	1057 (24.43%)	1167 (35.46%)

Statistical Analysis 1 for Cmax - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	93.90
90% Confidence Interval	( 83.45 to 105.65 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Cmax - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	84.35
90% Confidence Interval	( 74.97 to 94.91 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Cmax - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	101.15
90% Confidence Interval	( 92.55 to 110.55 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Cmax - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	94.06
90% Confidence Interval	( 86.06 to 102.79 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	5-Hydroxy Saxagliptin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Cmax - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	92.51
90% Confidence Interval	( 82.94 to 103.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Cmax - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	61.08
90% Confidence Interval	( 54.76 to 68.12 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Dapagliflozin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Cmax - Cohort 2

Groups^[1]	Treatment D, Treatment E
Other^[5]	95.96
90% Confidence Interval	( 86.36 to 106.63 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Bioequivalence Assessment
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Cmax - Cohort 2

Groups^[1]	Treatment E, Treatment F
Other^[5]	90.55
90% Confidence Interval	( 81.49 to 100.61 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Metformin - Food Effect Assessment
[5]	Other relevant estimation information:
	No text entered.

7. Secondary Outcome Measure: Time to reach maximum observed plasma concentration (tmax) - Cohort 1 and 2 [ Time Frame: At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours ]

Measure Type	Secondary
Measure Name	Time to reach maximum observed plasma concentration (tmax) - Cohort 1 and 2
Measure Description	To assess PK in terms of tmax in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers.
Time Frame	At pre-dose and post-dose at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Analysis Set: Participants who received at least 1 dose of study drug for whom at least 1 of the primary PK parameters could be calculated for at least 1 analyte (saxagliptin, 5-hydroxy saxagliptin, dapagliflozin or metformin) for 1 of the treatments within a Cohort and who had no major protocol deviations thought to impact on PK data analysis.

Reporting Groups

	Description
Treatment A	Randomized participants received single oral dose of reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment B	Randomized participants received single oral dose of test product - Triple Fixed - FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment C	Randomized participants received single oral dose of test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.
Treatment D	Randomized participants received single oral dose of reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment E	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment F	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.

Measured Values

	Treatment A	Treatment B	Treatment C	Treatment D	Treatment E	Treatment F
Number of Participants Analyzed [units:participants]	41	41	41	41	40	41
Time to reach maximum observed plasma concentration (tmax) - Cohort 1 and 2 [units: Hours] Median (Full Range)
Saxagliptin	1.50 (0.50 to 4.00)	1.52 (0.48 to 4.00)	0.50 (0.23 to 1.50)	2.00 (0.50 to 4.03)	1.99 (0.48 to 4.00)	0.50 (0.25 to 2.03)
5-Hydroxy Saxagliptin	3.00 (1.50 to 6.00)	3.00 (0.98 to 6.00)	1.50 (0.98 to 3.00)	3.00 (1.50 to 6.03)	3.00 (1.50 to 6.05)	1.50 (0.98 to 4.00)
Dapagliflozin	2.00 (1.00 to 5.98)	2.00 (0.98 to 6.00)	0.98 (0.48 to 1.50)	2.98 (1.00 to 6.02)	3.00 (1.00 to 6.05)	1.00 (0.50 to 2.00)
Metformin	5.98 (3.98 to 8.02)	5.98 (3.98 to 8.05)	4.00 (1.52 to 6.00)	6.00 (3.98 to 8.10)	6.00 (3.00 to 8.02)	4.00 (2.00 to 6.03)

No statistical analysis provided for Time to reach maximum observed plasma concentration (tmax) - Cohort 1 and 2

Serious Adverse Events

Time Frame

At Day -1, spontaneous plus pre-dose, 1, 2, 3, 24, and 48 hours post-dose.

Additional Description

An AE was development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, electrocardiogram). SAEs were recorded from the time of informed consent.

Reporting Groups

	Description
Treatment A	Randomized participants received single oral dose of reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment B	Randomized participants received single oral dose of test product - Triple Fixed - FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment C	Randomized participants received single oral dose of test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.
Treatment D	Randomized participants received single oral dose of reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment E	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment F	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.

Serious Adverse Events

	Treatment A	Treatment B	Treatment C	Treatment D	Treatment E	Treatment F
Total, serious adverse events
# participants affected / at risk	0/42 (0.00%)	0/41 (0.00%)	0/41 (0.00%)	0/42 (0.00%)	0/40 (0.00%)	0/41 (0.00%)

Other Adverse Events

Time Frame

At Day -1, spontaneous plus pre-dose, 1, 2, 3, 24, and 48 hours post-dose.

Additional Description

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Treatment A	Randomized participants received single oral dose of reference product - 2.5 mg saxagliptin (ONGLYZA) and 5 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment B	Randomized participants received single oral dose of test product - Triple Fixed - FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment C	Randomized participants received single oral dose of test product - Triple FCDP tablet: 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food.
Treatment D	Randomized participants received single oral dose of reference product - 5 mg saxagliptin (ONGLYZA) and 10 mg dapagliflozin / 1000 mg Metformin XR tablets (XIGDUO® XR) after food.
Treatment E	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food.
Treatment F	Randomized participants received single oral dose of test product - Triple FCDP tablet: 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food.

Other Adverse Events

Treatment A

Treatment B

Treatment C

Treatment D

Treatment E

Treatment F

Total, other (not including serious) adverse events

# participants affected / at risk

5/42 (11.90%)

1/41 (2.44%)

1/42 (2.38%)

2/40 (5.00%)

2/41 (4.88%)

Nervous system disorders

Headache¹

# participants affected / at risk

2/42 (4.76%)

0/41 (0.00%)

1/41 (2.44%)

1/42 (2.38%)

2/40 (5.00%)

0/41 (0.00%)

# events

Gastrointestinal disorders

Diarrhoea¹

# participants affected / at risk

2/42 (4.76%)

1/41 (2.44%)

0/42 (0.00%)

0/40 (0.00%)

0/41 (0.00%)

# events

Gastrointestinal disorders

Nausea¹

# participants affected / at risk

2/42 (4.76%)

0/41 (0.00%)

0/42 (0.00%)

0/40 (0.00%)

2/41 (4.88%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA version 20.0.

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor. This confidential document is the property of AstraZeneca AB. No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB. Access to this document must be restricted to relevant parties.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Weifeng Tang, M.D., Ph.D., Director, Quantitative Clinical Pharmacology.
Organization:	AstraZeneca LP
Phone	301 398 0341
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Trial Results Summaries