건강한 자원자에서 무르페® 패치와 트라스트® 패치 투여 시 약동학적 특성 및 피부자극성을 비교 평가하기 위한 무작위배정, 공개, 2-Way 교차 임상 연구

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 C<inf>max</inf> and AUC<inf>last</inf> values were not statistically different between two patch groups. Mean AUC<inf>[0-48h]</inf> was lower in Murupe® patch group than that in Trast® patch group; 806.4 and 1196.5 ng·h/mL. However, the mean AUC<inf>[48-120h]</inf> 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 AUC<inf>last</inf> values in Murupe® patch group were comparable to those in Trast® patch group. Murupe® patch was safe and well tolerated in healthy male subjects.