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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simvastatin | Active Comparator |
| |
| Dapagliflozin + simvastatin | Active Comparator |
| |
| Dapagliflozin | Active Comparator |
| |
| valsartan | Active Comparator |
| |
| Dapagliflozin + valsartan | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simvastatin | Drug | Tablets, Oral, 20 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 | 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of dapagliflozin when administered alone, with valsartan, or with simvastatin in healthy subjects | 15 timepoints | |
| To assess the safety and tolerability of the combination of dapagliflozin with valsartan, and the combination of dapagliflozin with simvastatin 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 |
|---|---|---|---|---|---|---|
| Mds Pharma Services (Us) Inc. | Neptune City | New Jersey | 07753 | United States |
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| Label | URL |
|---|---|
| MB102-036\_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 |
|---|---|
| D019821 | Simvastatin |
| C529054 | dapagliflozin |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Dapagliflozin | Drug | Tablets, Oral, 20 mg, Single Dose |
|
|
| simvastatin | Drug | Oral, 40 mg, Single Dose |
|
| valsartan | Drug | Tablets, Oral, 320 mg, Single Dose |
|
|
| 15 timepoints |
| To assess the effect of dapagliflozin on the PK of simvastatin acid (active metabolite of simvastatin), when coadministered in healthy subjects | 15 timepoints |
| D004700 | Endocrine System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |