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A bioequivalence study to compare and evaluate the pharmacokinetic characteristics and the safety after administration of DW5221 and DW5221-R in healthy adult m ale volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | cross-over |
|
| Sequence B | Experimental | cross-over |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DW5221 | Drug | megestrol acetate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Pharmacokinetics of Megestrol Acetate | up to 120 hour |
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetics of Megestrol Acetate | up to 120 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38586120 | Derived | Park SR, Hwang JG, Jeong SI, Choi YS, Min HJ, Kim HY, Choi BH, Park MK. Comparison of the pharmacokinetic characteristics and bioequivalence between two nanosuspension formulations of megestrol acetate in healthy Korean male subjects. Transl Clin Pharmacol. 2024 Mar;32(1):63-72. doi: 10.12793/tcp.2024.32.e6. Epub 2024 Mar 26. |
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| DW5221-R | Drug | megestrol acetate |
|
|