Journal Browser Advanced Search Help
Journal Browser Advanced search HELP
J Korean Soc Clin Pharmacol Ther. 2013 Dec;21(2):120-129. Korean. Original Article. https://doi.org/10.12793/jkscpt.2013.21.2.120
Kim MJ , Kim YH , Choi HY , Jeon HS , Noh YH , Lim HS , Bae KS .
Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, Seoul, Korea. ksbae13@gmail.com
Department of Clinical Pharmacology and Therapeutics, University of Ulsan College of Medicine, Seoul, Korea.
Department of Pharmacology, Inje University College of Medicine, Busan, Korea.
Department of Clinical Pharmacology, Inje University Busan Paik Hospital, Busan, Korea.
Abstract

BACKGROUND: This clinical study was conducted to compare pharmacokinetics of eperisone and aceclofenac of HCP1104, a new fixed dose combination drug with those in co-administration of eperisone 50 mg and aceclofenac 100 mg. The study used a partial replicated study design to characterize intra-subject variability of eperisone when co-administrated with aceclofenac. METHODS: A partial replicated crossover design was employed in 30 subjects. Each subject received a single dose of co-administration of eperisone 50 mg and aceclofenac 100 mg on two occasions and a single dose of 1 capsule of HCP1104. Blood samples were obtained for 24 hrs after dosing, and plasma was assayed for eperisone and aceclofenac by Liquid chromatography-electrospray ionization-mass spectrometry. RESULTS: Using an average bioequivalence criterion, the 90 % confidence limits for Ln-transformed Cmax and AUClast for aceclofenac fell wihin the acceptable range of 80 - 125 %. Point estimates of eperisone AUClast and Cmax were 1.0152 and 1.0490, respectively and the 90 % confidence interval for Cmax was 0.8499 - 1.3025. The within-subject coefficient of variation of Cmax for the reference was 50.198 %. Acceptance range for eperisone Cmax based on new bioequivalence guidance for highly variable drugs was extended to 0.6984 - 1.4319. CONCLUSION: The extent of exposure and rate of absorption of both eperisone and aceclofenac with a single dose of HCP1104 capsule were equivalent to those with co-administration of a marketed eperisone 50 mg tablet and a marketed aceclofenac 100 mg tablet under fasting conditions in healthy adult males.

Copyright © 2019. Korean Association of Medical Journal Editors.