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| ID | Type | Description | Link |
|---|---|---|---|
| 118,840 | Other Identifier | IND Number |
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The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE of Saxagliptin and Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered orally together in the fasted state. Demonstrating bioequivalence refers to showing that the FDC tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly.
Primary Purpose: This study is designed to demonstrate the bioequivalence of Saxagliptin and Dapagliflozin from a FDC tablet after oral administration relative to Saxagliptin and Dapagliflozin tablets administered orally together in the fasted and fed state
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Saxagliptin 2.5mg+Dapagliflozin 5mg; Fasting | Other | Saxagliptin 2.5 mg tablet and Dapagliflozin 5 mg tablet single dose orally on Day 1 in one of 3 periods |
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| Treatment B: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fasting | Other | Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods |
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| Treatment C: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fed | Other | Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods |
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| Treatment D: Saxagliptin 5mg+Dapagliflozin 10mg; Fasting | Other | Saxagliptin 5 mg tablet and Dapagliflozin 10 mg tablet single dose orally for on Day 1 in one of 3 periods |
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| Treatment E: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fasting | Other | Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin | 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [(AUC(0-T)] for Saxagliptin and Dapagliflozin | 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days | |
| Area under the concentration-time curve from time zero extrapolated to infinite time [(AUC(INF)] for Saxagliptin and Dapagliflozin | 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for 5-hydroxy (OH) Saxagliptin | 54 time points up to 15 days | |
| AUC(0-T) for 5-hydroxy (OH) Saxagliptin | 54 time points up to 15 days | |
| AUC(INF) for 5-hydroxy (OH) Saxagliptin |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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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 |
| C529054 | dapagliflozin |
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|
| Treatment F: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fed | Other | Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods |
|
| Dapagliflozin | Drug |
|
|
| Saxagliptin/Dapagliflozin FDC | Drug |
|
|
| 54 time points up to 15 days |
| Time of maximum observed plasma concentration (Tmax) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin | 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days |
| Percent of AUC extrapolated from last quantifiable concentration to infinity (pAUCe) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin | 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days |
| Half life (T HALF) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin | 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days |
| Terminal disposition rate constant (Lambda) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin | 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days |
| Time point where log-linear elimination begins (TLIN) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin | 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days |
| Time at which the last concentration occurred that is above the lower limit of quantitation (LQCT) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin | 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days |
| Safety measured by the occurrence of deaths, adverse events (AEs), serious adverse events (SAEs), results of clinical laboratory tests, vital sign measurements, physical examination findings, and 12-lead electrocardiogram (ECG) results | Approximately up to 16 days |
| D004700 | Endocrine System Diseases |