Pharmacokinetics and Safety Study of Apetrol ES

Phase 1 Completed 79 enrolled LG Life Sciences Severance Hospital · collab

RandomizedCrossoverOpen-labelTreatment

Summary

A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® in Healthy Male Volunteers.

Timeline

Start: 2010-04
Primary completion: 2010-06
Completion: 2010-10

Outcome

Mixed primary results

paper Bioequivalence evaluation was based on the standard criterion of 80 - 125% for the 90% confidence interval of geometric mean ratios PMID 27191767 ↗

paper The 90% CIs of the geometric mean ratios of C<sub>max</sub> and AUC<sub>last</sub> were 4.4625 - 5.6018 and 1.3602 - 1.6418, respectively, for part 1 PMID 27191767 ↗

paper and 0.9793 - 1.1327 and 0.7721 - 0.8431, respectively, for part 2. PMID 27191767 ↗

Publications

Chae DW, Son H, Guk J, Park C, Park K. Pharmacokinetics of a nanocrystal-containing megestrol acetate formulation: a single-dose, randomized, open-label, 2-part, 2-period crossover study in healthy Korean subjects. Int J Clin Pharmacol Ther. 2016 Sep;54(9):698-704. doi: 10.5414/CP202574.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Megestrol Acetate	Other / unclassified	625 mg	—
Subject	Megestrol Acetate	Other / unclassified	800 mg	—

Indications

No indication recorded.