Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-R

Phase 1 Completed 54 enrolled Daewon Pharmaceutical Co., Ltd.

RandomizedCrossoverOpen-labelTreatment

Summary

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

Timeline

Start: 2022-07-01
Primary completion: 2022-10-26
Completion: 2022-11-17

Outcome

Met primary endpoint

paper The test formulation met regulatory criteria for bioequivalence. PMID 38586120 ↗

paper The 90% confidence intervals for the geometric mean ratios of the test formulation compared to the reference formulation were 93.85% to 108.90% PMID 38586120 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Megestrol Acetate	Other / unclassified	625 mg	Oral

Indications

No indication recorded.