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2013 (v.21 no.2)

The Journal of Korean Society for Clinical Pharmacology and Therapeutics

Korean Society for Clinical Pharmacology and Therapeutics
Semiannual
ISSN: 1225-5467

  • Bioequivalence of HCP1104, a New Fixed Dose Combination Drug and Co-administration of Eperisone 50 mg and Aceclofenac 100 mg: A Partial Replicated Crossover Study Design to Estimate the Pharmacokinetics of Highly Variable Drugs

    Mi Jo Kim, Yo Han Kim, Hee Youn Choi, Hae Sun Jeon, Yook Hwan Noh, Hyeong-Seok Lim, Kyun-Seop Bae

    J Korean Soc Clin Pharmacol Ther | v.21, no.2, pp.120-129, Dec, 2013

    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.

    Keyword

    Highly variable drugs, Bioequivalence, Eperisone, Aceclofenac