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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Other: FDC of dapagliflozin/metformin XR | Drug: Dapagliflozin Tablets, Oral, 10 mg, Single Dose Drug: Metformin XR Tablets, Oral, 1000 mg, Single Dose |
| Other: FDC of dapagliflozin/reduced mass metformin XR | Drug: Dapagliflozin Tablets, Oral, 10 mg, Single Dose Drug: Metformin XR Tablets, Oral, 1000 mg, Single Dose |
| Other: dapagliflozin and Glucophage® XR | Drug: Dapagliflozin Tablets, Oral, 10 mg, Single Dose Drug: Glucophage Tablets, Oral, 1000 mg, Single Dose Other Name: Glucophage™ |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
