Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Diabetes Mellitus, Non-Insulin-Dependent |
| Intervention | Drug: Dapagliflozin Drug: Metformin XR Drug: Glucophage |
| Phase | Phase 1 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT01002807 |
| First Received | October 26, 2009 |
| Last Updated | February 22, 2011 |
| Last verified | January 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 26, 2009 |
|---|---|
| Last Updated Date | February 22, 2011 |
| Start Date | November 2009 |
| Estimated Primary Completion Date | January 2010 |
| Current Primary Outcome Measures | Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone [Time Frame: 48 hours post-dose] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments) [Time Frame: 15 timepoints in 48 hours time interval] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State |
|---|---|
| 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 |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label |
| Condition | Diabetes Mellitus, Non-Insulin-Dependent |
| Intervention | Drug: Dapagliflozin Tablets, Oral, 10 mg, Single Dose Drug: Metformin XR Tablets, Oral, 1000 mg, Single Dose Drug: Glucophage Tablets, Oral, 1000 mg, Single Dose Other Names: Glucophage™ |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 15 |
| Estimated Completion Date | January 2010 |
| Estimated Primary Completion Date | December 2009 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01002807 |
|---|---|
| Other Study ID Numbers | MB102-065 |
| Has Data Monitoring Committee | No |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | AstraZeneca |
| Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
| Verification Date | January 2010 |
Locations[ + expand ][ + ]
| Ppd Development, Lp | Austin, Texas, United States, 78744 |
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