임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

건강한 자원자에서 무르페$^{(R)}$ 패치와 트라스트$^{(R)}$ 패치 투여 시 약동학적 특성 및 피부자극성을 비교 평가하기 위한 무작위배정, 공개, 2-Way 교차 임상 연구

A Randomized, Open Label, 2-Way Crossover Study to Assess the Pharmacokinetic Characteristics and Skin Irritation of Murupe$^{(R)}$ Patch Compared with Trast$^{(R)}$ Patch in Healthy Volunteers

  • 최윤정 (서울대학교 의과대학 임상약리학교실 및 서울대학교병원 임상약리학과) ;
  • 김영미 (한양대학교 약학대학 약학과) ;
  • 정재용 (서울대학교 의과대학 임상약리학교실 및 서울대학교병원 임상약리학과) ;
  • 조주연 (서울대학교 의과대학 임상약리학교실 및 서울대학교병원 임상약리학과) ;
  • 유경상 (서울대학교 의과대학 임상약리학교실 및 서울대학교병원 임상약리학과) ;
  • 장인진 (서울대학교 의과대학 임상약리학교실 및 서울대학교병원 임상약리학과) ;
  • 임경수 (서울대학교 의과대학 임상약리학교실 및 서울대학교병원 임상약리학과)
  • Choi, Yoon Jung (Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital) ;
  • Kim, Young Mi (College of Pharmacy, Hanyang University) ;
  • Chung, Jae-Yong (Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital) ;
  • Cho, Joo-Youn (Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital) ;
  • Yu, Kyung-Sang (Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital) ;
  • Jang, In-Jin (Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital) ;
  • Lim, Kyoung Soo (Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital)
  • 투고 : 2013.06.19
  • 심사 : 2013.06.26
  • 발행 : 2013.06.30
⟨ 이전 논문 다음 논문 ⟩

초록

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$^{(R)}$ patch (piroxicam 96 mg) compared with Trast$^{(R)}$ 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$^{(R)}$ 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 $C_{max}$ and $AUC_{last}$ values were not statistically different between two patch groups. Mean $AUC_{[0-48h]}$ was lower in Murupe$^{(R)}$ patch group than that in Trast$^{(R)}$ patch group; 806.4 and $1196.5ng{\cdot}h/mL$. However, the mean $AUC_{[48-120h]}$ value tended to be higher in Murupe$^{(R)}$ patch group, implying more delayed excretion than in Trast$^{(R)}$ patch group; $2724.7ng{\cdot}h/mL$ and $1989.2ng{\cdot}h/mL$. The overall results of skin irritation potential test showed no clinically significant differences between two patch groups. Conclusion: Mean $C_{max}$ and $AUC_{last}$ values in Murupe$^{(R)}$ patch group were comparable to those in Trast$^{(R)}$ patch group. Murupe$^{(R)}$ patch was safe and well tolerated in healthy male subjects.

키워드

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