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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses of 5 mg saxagliptin in healthy Chinese subjects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin | Multiple timepoints during 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables for saxagliptin's active metabolite BMS-510849 after single and multiple oral doses of 5 mg saxagliptin | Multiple time points during 9 days | |
| Safety variables (adverse events reported, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests after single and multiple oral doses of 5 mg saxagliptin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Öhman, MD, PhD | AstraZeneca | Study Director |
| Deborah Price, MSc | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22668067 | Derived | Li H, Yang L, Tou CK, Patel CG, Zhao J. Pharmacokinetic study of saxagliptin in healthy Chinese subjects. Clin Drug Investig. 2012 Jul 1;32(7):465-73. doi: 10.2165/11598760-000000000-00000. |
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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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| Multiple time points during 10 days (including measurements before dosing) |
| D004700 | Endocrine System Diseases |