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To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | Tablets, oral, 2.5 mg, twice daily, 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects | Within the first 24 hours of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the steady-state pharmacodynamics of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects | 18 time points up to 14 hours on two separate study days | |
| To assess the PK of the pharmacologically active major metabolite of saxagliptin, BMS-510849, following administration of 2.5 mg saxagliptin twice daily with meals to 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 |
|---|---|---|---|---|---|---|
| Ppd Development, Lp | Austin | Texas | 78744 | United States |
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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 |
|---|---|
| C502994 | saxagliptin |
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| 21 time points up to 23 hours after first dosing |
| To assess the safety and tolerability of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects | Day 1 to Day 7 |
| D004700 | Endocrine System Diseases |