PK and Safety Study of HCP1102, HGP0813 and HGP1408

Phase 1 Completed 24 enrolled Hanmi Pharmaceutical Company Limited

RandomizedCrossoverOpen-labelBasic science

Summary

This study is a randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of HCP1102 in comparison to HGP0813 and HGP1408 administered in healthy male volunteers.

Timeline

Start: 2017-07-19
Primary completion: 2017-08-03
Completion: 2017-08-03

Publications

Moon SJ, Yu KS, Jung J, Kim YI, Kim MG. Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast and levocetirizine after a single oral administration in healthy Korean male subjects . Int J Clin Pharmacol Ther. 2020 Jun;58(6):354-362. doi: 10.5414/CP203709.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levocetirizine	Unknown	5 mg	Oral
Subject	Montelukast	Other / unclassified	5 mg	Oral

Indications

No indication recorded.