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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, 20 mg, once daily single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment | measures taken daily throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment | measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period) |
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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 |
|---|---|---|---|---|---|---|
| Bristol-Myers Squibb Clinical Pharmacology Unit | Hamilton | New Jersey | 08690 | United States |
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| Label | URL |
|---|---|
| MB102026 \_Redacted \_CSR \_synopsis | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| 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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| Metformin |
| Drug |
Tablets, Oral, 1000 mg, once daily, single dose |
|
| Dapagliflozin + Metformin | Drug | Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg |
|