Bioavailability Study of fixed dose combination (FDC) Formulations of Dapagliflozin and Metformin XR versus Individual Component Coadministered to Healthy Subjects in a Fasted State

Study identifier:MB102-065

ClinicalTrials.gov identifier:NCT01002807

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Bioavailability Study of Two Prototype Fixed Dose Combination (FDC) Formulations of 10 mg Dapagliflozin and 1000 mg Metformin Extended Release (XR) Tablet Relative to Dapagliflozin 10 mg Tablet and Glucophage® XR 2 X 500 mg Tablets Coadministered to Healthy Subjects in a Fasted State

Medical condition

Type 2 Diabetes Mellitus (T2DM)

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Dapagliflozin, Metformin XR, Glucophage

Sex

All

Actual Enrollment

15

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Nov 2009
Primary Completion Date: 01 Dec 2009
Study Completion Date: 01 Jan 2010

Study design

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Oct 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria