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The purpose of this study is to evaluate drug-drug interaction by comparing the pharmacokinetics (PK)/pharmacodynamics (PD), safety, and tolerability of single/multiple doses of DWP16001 , DWC202001 and DWC202002 alone or in combination in healthy male adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| Experimental 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 | Drug | Tablets, Oral, once daily single dose |
| |
| DWC202001+DWC202002 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of DWP16001 | Peak Plasma Concetration | 0-72 hours |
| AUClast of DWP16001 | Area under the plasma concentration versus time curve | 0-72 hours |
| Cmax,ss of DWC202001 and DWC202002 | Peak Plasma Concetration at steady-state | 0-72 hours |
| AUCÏ„,ss of DWC202001 and DWC202002 | Area under the plasma concentration versus time curve at Tau, steady-state | 0-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of DWP 16001, DWC202001 and DWC202002 | Time at Cmax | 0-72 hours |
| T1/2 of DWP 16001, DWC202001 and DWC202002 | 0-72 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Hyun Choi | Contact | 82-02-550-8406 | jhchoi413@daewoong.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000729921 | Enavogliflozin |
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| Drug |
Tablets, Oral, multiple doses of DWC202001 and DWC202002 in combination |
|
| DWP16001+DWC202001+DWC202002 | Drug | Tablets, Oral, DWP16001 , DWC202001 and DWC202002 in combination |
|
| CL/F of DWC202001 and DWC202002 |
| 0-72 hours |