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2013 (v.21 no.1)

The Journal of Korean Society for Clinical Pharmacology and Therapeutics

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

  • A Randomized, Open Label, 2-Way Crossover Study to Assess the Pharmacokinetic Characteristics and Skin Irritation of Murupe® Patch Compared with Trast® Patch in Healthy Volunteers

    Yoon Jung Choi, Young Mi Kim, Jae-Yong Chung, Joo-Youn Cho, Kyung-Sang Yu, In-Jin Jang, Kyoung Soo Lim

    J Korean Soc Clin Pharmacol Ther | v.21, no.1, pp.41-51, Jun, 2013

    Abstract

    Background :A piroxicam patch has been widely used to treat musculoskeletal pain. The aim of this
    study was to assess the pharmacokinetic (PK) characteristics and skin irritation of Murupe® patch
    (piroxicam 96 mg) compared with Trast® patch (piroxicam 96 mg) in healthy volunteers.
    Methods :A randomized, open-label, 2-way crossover study was conducted in 12 healthy Korean male
    subjects. They were allocated to one of the two treatment sequences of RT and TR (R, reference drug,
    Trast® patch; T, test drug, Murupe® patch). Each patch was applied to the subject once during 48 hours.
    Serial blood samples were collected up to 72 hours after removing the patch and plasma concentrations
    were determined by high performance liquid chromatography. Safety was monitored and the skin
    irritation potential was assessed.
    Results :The plasma concentration?time profile during 48 hours showed an exponential increase in both
    of two patch products. Mean Cmax and AUClast values were not statistically different between two patch
    groups. Mean AUC[0-48h] was lower in Murupe® patch group than that in Trast® patch group; 806.4 and
    1196.5 ng·h/mL. However, the mean AUC[48-120h] value tended to be higher in Murupe® patch group,
    implying more delayed excretion than in Trast® patch group; 2724.7 ng·h/mL and 1989.2 ng·h/mL. The
    overall results of skin irritation potential test showed no clinically significant differences between two
    patch groups.
    Conclusion : Mean Cmax and AUClast values in Murupe® patch group were comparable to those in
    Trast® patch group. Murupe® patch was safe and well tolerated in healthy male subjects.

    Keyword

    Piroxicam patch, Pharmacokinetics, Skin irritation