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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Active Comparator |
| |
| Glimepiride | Active Comparator |
| |
| Dapagliflozin + Glimepiride | Active Comparator |
| |
| Sitagliptin | Active Comparator |
| |
| Dapagliflozin + Sitagliptin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | 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 after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability in healthy subjects | 15 time points up to 72 hours after dosing |
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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 | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| MB102-037\_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 |
| C057619 | glimepiride |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Glimepiride | Drug | Tablets, Oral, 4 mg, Single Dose |
|
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| Sitagliptin | Drug | Tablets, Oral, 100 mg, Single Dose |
|
|
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |