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This is a randomized, open label, single dose, crossover study to compare the pharmacokinetics and safety between "DWJ1421" and "DWC201903" in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (RT) | Experimental | Period 1 : Reference drug (DWC201903) Period 2 : Test durg(DWJ1421) |
|
| B (TR) | Experimental | Period 1 : Test durg(DWJ1421) Period 2 : Reference drug (DWC201903) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWJ1421 | Drug | 1 tablet administered in fasting condition |
| |
| DWC201903 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration of DWJ1421 | 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h |
| AUClast | Area under the drug concentration-time curve | 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang CHA Medical Center | Seongnam-si | Gyeonggi-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33062629 | Derived | Shin W, Yang AY, Yun H, Cho DY, Park KH, Shin H, Kim A. Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects. Transl Clin Pharmacol. 2020 Sep;28(3):160-167. doi: 10.12793/tcp.2020.28.e13. Epub 2020 Sep 21. |
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| Drug |
1 tablet administered in fasting condition |
|