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This study aims to compare the pharmacokinetics and safety following administration of DWJ1567 and DWC202312 in healthy volunteers
The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1567 and DWC202312. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1567 and DWC202312.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWJ1567 | Experimental | DWJ1567 |
|
| DWC202312 | Active Comparator | DWC202312 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWJ1567 | Drug | One tablet of DWJ1567 |
| |
| DWC202312 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss of DWJ1567 and DWC202312 | At pre-dose (0 hour), and post-dose 0 to 72 hour. | |
| AUCt of DWJ1567 and DWC202312 | At pre-dose (0 hour), and post-dose 0 to 72 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of DWJ1567 and DWC202312 | At pre-dose (0 hour), and post-dose 0 to 72 hour | |
| Tmax of DWJ1567 and DWC202312 | At pre-dose (0 hour), and post-dose 0 to 72 hour | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung-Hyun Kang, MD, Ph D | Contact | 070-4665-9490 | juspa@newyjh.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus YANGJI Hospital | Recruiting | Seoul | South Korea |
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| Drug |
One tablet of DWC202312 |
|
| AUCt/AUCinf of DWJ1567 and DWC202312 |
| At pre-dose (0 hour), and post-dose 0 to 72 hour |
| t1/2 of DWJ1567 and DWC202312 | At pre-dose (0 hour), and post-dose 0 to 72 hour |