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Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults
A phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of DWC202511 or DWC202512 on the pharmacokinetics of DWP16001 and its metabolite in healthy adult subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 | Drug | DWP16001 enavogliflozin (single oral dose) is administered in accordance with the study protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 1 week | |
| AUClast | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | AUCinf of DWP16001 and DWP16001 metabolites | 1 week |
| t1/2 | t1/2 of DWP16001 and DWP16001 metabolites | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
Current or history of urinary tract infection or genital fungal infection.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jong No Gu | 03080 | South Korea |
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| ID | Term |
|---|---|
| C000729921 | Enavogliflozin |
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| DWC202511 | Drug | Repeated oral administration of DWC202511 500 mg twice daily (BID), in accordance with the study protocol. |
|
| DWC202512 | Drug | Repeated oral administration of DWC202512 once daily, in accordance with the study protocol |
|
| Tmax | Tmax of DWP16001 and DWP16001 metabolites | 1 week |
| CL/F | CL/F of DWP16001 | 1 week |
| Vz/F | Vz/F of DWP16001 | 1 week |
| metabolic ratio | metabolic ratio of DWP16001 metabolites | 1 week |