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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet |
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| 2 | Experimental | Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets |
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| 3 | Experimental | Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet |
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| 4 | Experimental | Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin/Metformin | Drug | Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin. | Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP. |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the safety and tolerability of the combination of dapagliflozin and metformin. | Throughout study (for 4 days in each period and a follow-up visit ~6 days later) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georg Golor, M.D. | Parexel | Principal Investigator |
| Thomas Koernicke | Parexel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Dapagliflozin | Drug | dapagliflozin tablet 2.5 mg Oral Single dose |
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| Metformin | Drug | metformin IR tablet 850 mg Oral Single dose |
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| Dapagliflozin/Metformin | Drug | Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose |
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| Dapagliflozin | Drug | dapagliflozin tablet 5 mg Oral Single dose |
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| Metformin | Drug | metformin IR tablet 1000 mg Oral Single dose |
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