Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
Completed · Phase 1
Conditions studied: Type 2 Diabetes Mellitus (T2DM)
In brief
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.
Key facts
- Study ID
- NCT01002807
- Run by
- AstraZeneca
- People needed
- 15
- Starts
- 2009-11-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2016-10-17
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ppd Development, Lp — Austin, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.