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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 , DWC202204 and DWC202205 alone or in combination in healthy male adults.
* Open label, multiple dose, 2 part, two period, single sequence design. This study is conducted on open label because it evaluates PK/PD parameters that are not affected by the blind. Volunteers who are suitable for the inclusion criteria are granted the final target number before the first dosage, receiving a fixed IP, and conducting a planned clinical trial schedule.
After having a rest period (7 days) in which the drug received is sufficiently metabolized and lost, the IP of the next period is administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental |
| |
| Experimental 2 | Experimental |
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| Experimental 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 | Drug | Tablets, Oral, multiple doses of DWP16001 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss of DWP16001 | Peak Plasma Concetration at steady-state | [Time Frame: 0-72 hours] |
| AUCtau,ss of DWP16001 | Area under the plasma concentration versus time curve at Tau, steady-state | [Time Frame: 0-72 hours] |
| Cmax,ss of DWC202204 and DWC202205 | Peak Plasma Concetration at steady-state | [Time Frame: 0-24 hours] |
| AUCtau,ss of DWC202204 and DWC202205 | Area under the plasma concentration versus time curve at Tau, steady-state | [Time Frame: 0-24 hours] |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C000729921 | Enavogliflozin |
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| DWC202204+DWC202205 |
| Drug |
Tablets, Oral, multiple doses of DWC202204 and DWC202205 in combination |
|
| DWP16001+DWC202204+DWC202205 | Drug | Tablets, Oral, DWP16001 , multiple doses of DWC202204 and DWC202205 in combination |
|