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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is determine that Dapagliflozin has no effect on the pharmacokinetics (PK) or pharmacodynamics (PD) of warfarin when dapagliflozin is coadministered with warfarin. Also, that Dapagliflozin has no effect on the PK of digoxin when dapagliflozin is coadministered with digoxin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin + Warfarin | Active Comparator |
| |
| Warfarin | Active Comparator |
| |
| Dapagliflozin + Digoxin | Active Comparator |
| |
| Digoxin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, 20 mg, followed by 10 mg, Single Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs | 216 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of dapagliflozin on the PK of R-warfarin, when warfarin and dapagliflozin are coadministered in healthy subjects (Cohort 1) | 16 time points | |
| To assess the safety and tolerability of the combination of dapagliflozin with warfarin, and the combination of dapagliflozin with digoxin in healthy subjects |
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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 |
|---|---|---|---|---|---|---|
| Pra International | Lenexa | Kansas | 66219 | United States |
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| Label | URL |
|---|---|
| MB102-058\_redacted \_CSR \_synopsis | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D014859 | Warfarin |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Warfarin | Drug | Tablets, Oral, 25 mg, Single Dose |
|
|
| Digoxin | Drug | Tablets, Oral, 0.25, Single Dose |
|
|
| 16 time points |
| D004700 | Endocrine System Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |