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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDC of dapagliflozin/metformin XR | Other |
| |
| FDC of dapagliflozin/reduced mass metformin XR | Other |
| |
| dapagliflozin and Glucophage® XR | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, 10 mg, Single Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone | 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments) | 15 timepoints in 48 hours time interval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ppd Development, Lp | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| MB102-065\_redacted\_CSR\_synopsis | View source |
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| Metformin XR | Drug | Tablets, Oral, 1000 mg, Single Dose |
|
| Glucophage | Drug | Tablets, Oral, 1000 mg, Single Dose |
|
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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