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This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6013 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: Linagliptin and Metformin / Period 2: DW6013 |
|
| Sequence B | Experimental | Period 1: DW6013 / Period 2: Linagliptin and Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DW6013 | Drug | Drug: DW6013 Single oral administration of DW6013 after an overnight fast Drug: Linagliptin and Metformin Single oral administration of Linagliptin and Metformin after an overnight fast |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | AUC0-t of Linagliptin and Metformin | up to 72 hours |
| Cmax | Cmax of Linagliptin and Metformin | up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Tmax of Linagliptin and Metformin | up to 72 hours |
| AUCinf | AUCinf of Linagliptin and Metformin | up to 72 hours |
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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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| ID | Term |
|---|---|
| C585596 | Jentadueto |
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|
| AUCextra | AUCextra of Linagliptin and Metformin | up to 72 hours |
| t1/2 | t1/2 of Linagliptin and Metformin | up to 72 hours |
| CL/F | CL/F of Linagliptin and Metformin | up to 72 hours |
| Vd/F | Vd/F of Linagliptin and Metformin | up to 72 hours |