Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

NCT01342055 ↗

Phase 1 Completed 38 enrolled LG Life Sciences Asan Medical Center · 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® under Fed Conditions in Healthy Male Volunteers.

Timeline

Start: 2011-03
Primary completion: 2011-05
Completion: 2011-08

Publications

Kim YH, Choi HY, Jin S, Noh YH, Kim MJ, Park HJ, Lim HS, Bang K, Lee SH, Bae KS. Tolerability and pharmacokinetics of two formulations of megestrol acetate under fed conditions in healthy volunteers. Clin Ther. 2015 Feb 1;37(2):439-47. doi: 10.1016/j.clinthera.2014.09.022. Epub 2014 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Megestrol Acetate	Other / unclassified	650 mg	Oral
Subject	Megestrol Acetate	Other / unclassified	675 mg	Oral

Indications

No indication recorded.