Phase I Multiple-Ascending Dose (Japan) - MAD

Study identifier:MB102-025

ClinicalTrials.gov identifier:NCT00538174

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 1

Healthy volunteers

Study drug

Dapagliflozin, placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 70 Years

Date

Study Start Date: 01 Nov 2007

Primary Completion Date: 01 May 2008

Study Completion Date: 01 May 2008

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2016 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: Arm 1 2.5 mg	Drug: Dapagliflozin Tablets, Oral, once daily up, to 14 days
Experimental: Arm 2 10 mg	Drug: Dapagliflozin Tablets, Oral, once daily up, to 14 days
Experimental: Arm 3 20 mg	Drug: Dapagliflozin Tablets, Oral, once daily up, to 14 days
Placebo Comparator: Arm 4	Drug: placebo Tablets, Oral, 0 mg, once daily, up to 14 days

Documents available

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Download
MB102025 _Redacted _CSR _synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator