Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
Phase 1
Completed
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Interventions
- Registration Number
- NCT01002807
- Lead Sponsor
- AstraZeneca
- 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 dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description FDC of dapagliflozin/reduced mass metformin XR Metformin XR - FDC of dapagliflozin/metformin XR Metformin XR - FDC of dapagliflozin/reduced mass metformin XR Dapagliflozin - dapagliflozin and Glucophage® XR Glucophage - FDC of dapagliflozin/metformin XR Dapagliflozin - dapagliflozin and Glucophage® XR Dapagliflozin -
- Primary Outcome Measures
Name Time Method Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone 48 hours post-dose
- Secondary Outcome Measures
Name Time Method Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments) 15 timepoints in 48 hours time interval
Trial Locations
- Locations (1)
Ppd Development, Lp
🇺🇸Austin, Texas, United States