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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dapagliflozin (0.001 mg) | Experimental | Cohort 1 |
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| dapagliflozin (0.01 mg) | Experimental | Cohort 2 |
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| dapagliflozin (0.1 mg) | Experimental | Cohort 3 |
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| dapagliflozin (0.3 mg) | Experimental | Cohort 4 |
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| dapagliflozin (1 mg) | Experimental | Cohort 5 |
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| dapagliflozin (2.5 mg) | Experimental | Cohort 6 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapagliflozin | Drug | Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect | 24 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 24 hours after dosing | |
| Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics | 2 days 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, Lp | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| MB102-088\_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 |
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| dapagliflozin | Drug | Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days |
|
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| dapagliflozin | Drug | Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days |
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| dapagliflozin | Drug | Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days |
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| dapagliflozin | Drug | Tablets, Oral, 1 mg, once on Day 1 only, 2 days |
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| dapagliflozin | Drug | Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days |
|
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| D004700 | Endocrine System Diseases |