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This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6014 and each component in healthy adult volunteers in fast condition.
This is a Phase 1, randomized, open-label, Oral, Single-dose, two-way crossover study in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1: Empagliflozin and Metformin Period 2: DW6014 |
|
| Sequence B | Experimental | Period 1: DW6014 Period 2: Empagliflozin and Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DW6014 | Drug | Drug: DW6014 Single oral administration of DW6014 after an overnight fast Drug: Empagliflozin and Metformin Combination oral administration of Empagliflozin and Metformin after an overnight fast |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | AUC0-t of Empagliflozin and Metformin | 48 hour |
| Cmax | Cmax of Empagliflozin and Metformin | 48 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Tmax of Empagliflozin and Metformin | 48 hour |
| AUCinf administration to infinity) | AUCinf of Empagliflozin and Metformin | 48 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | South Korea |
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|
| t1/2 | t1/2 of Empagliflozin and Metformin | 48 hour |
| CL/F | CL/F of Empagliflozin and Metformin | 48 hour |
| Vd/F | Vd/F of Empagliflozin and Metformin | 48 hour |
| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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