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An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWC202211 | Experimental |
| |
| DWC202212 | Experimental |
| |
| DWC202211 + DWC202212 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWC202211 100mg | Drug | DWC202211 for 5 days Aspirin 100mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | up to 27 days | |
| AUClast | up to 27 days |
| Measure | Description | Time Frame |
|---|---|---|
| DWC202211 Tmax,ss | up to 27 days | |
| DWC202211 T1/2,ss | up to 27 days | |
| DWC202211 Cmin,ss |
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Inclusion Criteria:
Healthy adults aged ≥ 19 and ≤ 50 years at screening
Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening
※ BMI (kg/m2) = body weight (kg)/[height (m)]2
Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| DWC202212 5mg |
| Drug |
DWC202212 for 3 days Rabeprazole 5mg |
|
| DWC202211 100mg + DWC202212 5mg | Drug | DWC202211 + DWC202212 for 5 days Aspirin 100mg, Rabeprazole 5mg |
|
| up to 27 days |
| DWC202211 Cavg,ss | up to 27 days |
| DWC202211 CLss/F | up to 27 days |
| DWC202211 Vdss/f | up to 27 days |
| DWC202211 PTF | up to 27 days |
| DWC202212 Tmax,ss | up to 27 days |
| DWC202212 T1/2,ss | up to 27 days |
| DWC202212 Cmin,ss | up to 27 days |
| DWC202212 Cavg,ss | up to 27 days |
| DWC202212 CLss/F | up to 27 days |
| DWC202212 Vdss/f | up to 27 days |
| DWC202212 PTF | up to 27 days |