Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State

Exclusion Criteria

• - Any significant acute or chronic medical illness.
• - Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
• - Any other sound medical, psychiatric, and/or social reason as determined by the investigator
• - Any major surgery within 4 weeks of study drug administration.
• - Any prior GI surgery including cholecystectomy (remote history of appendectomy will not be exclusionary).
• - Current, recent (within 3 months of study drug administration), or remote history of pancreatitis.
• - Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 4 weeks before study drug administration.
• - Blood transfusion within 4 weeks of study drug administration. h) Inability to tolerate oral medication.
• - Inability to be venipunctured performed and/or tolerate venous access.
• - Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, e-cigarettes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months before check-in.
• - Drug or alcohol abuse (within 2 years of study drug administration) as defined in the Diagnostic and Statistical Manual of Mental Disorders - 4th Edition, Diagnostic Criteria for Drug and Alcohol Abuse
• History of glucose intolerance or diabetes mellitus.
• - For females, history of chronic or recurrent urinary tract infection (UTI) (defined as
• 3 occurrences per year) or UTI in the past 3 months. For males, any UTI within the previous 5 years that has not been thoroughly evaluated and for which an explanation is not clear.
• - History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections.
• - Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
• Physical and Laboratory Test Findings
• a) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population.
• b) Abnormal urinalysis at screening (may repeat once). If the urinalysis is abnormal on Day -1 of Period 1, continuation in the study is up to the investigator’s discretion. The CRO medical monitor should be consulted.
• c) Glucosuria or hematoria at screening or Day -1 of Period 1, repeat is not permitted. d) A positive nicotine test (ie, cotinine).
• e) Abnormal liver function tests (alanine or aspartate aminotransferase [ALT or AST, respectively], or total bilirubin).
• f) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.
• i) PR ≥ 210 ms ii) QRS ≥ 120 ms iii) QT ≥ 500 ms
• iv) QTcF ≥ 450 ms
• g) Positive urine screen for drugs of abuse. h) Positive urine alcohol test.
• i) Positive blood screen for hepatitis C virus (HCV) antibody, hepatitis B surface antigen
• (HBsAg), or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at screening.
• 4. Allergies and Adverse Drug Reaction
• a) History of allergy or adverse reactions to DPP4 or SGLT inhibitors or related compounds.
• b) History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
• 5. Other Exclusion Criteria
• a) Prisoners or subjects who are involuntarily incarcerated.
• b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical
• (eg, infectious disease) illness.
• c) Inability to comply with restrictions and prohibited activities/treatments