Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin; Metformin

Criteria

Inclusion Criteria:

• Men and women ages 18 to 45 inclusive

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

• Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2

Exclusion Criteria:

• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product

• Any significant acute or chronic medical illness

• Current or recent (within 3 months) gastrointestinal disease

• Any major surgery within 4 weeks of study drug administration

• Glucosuria at screening

• Abnormal liver functions tests (ALT, AST or total bilirubin > 10% above ULN)

• Presence of edema on physical exam

• History of diabetes mellitus

• History of heart failure

• History of renal insufficiency

• History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months

• History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections

• Estimated creatinine clearance (ClCR) of < 80 mL/min using the Cockcroft Gault formula

• History of allergy or intolerance to metformin or other similar agents