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
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
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.