Status:
COMPLETED
Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 dapagl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01002807
Start Date
November 1 2009
End Date
January 1 2010
Last Update
October 17 2016
Active Locations (1)
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1
Ppd Development, Lp
Austin, Texas, United States, 78744