日本人健康成人男性におけるナルトレキソン併用下のフェンタニル3日用テープ貼付時の安全性および薬物動態に関する同等性試験

抄録

FENTANYL Tape for 3 days 2.1 mg 「MEIJI」(fentanyl M) is an adhesive preparation containing the same amount of fentanyl as Durotep^® MT Patch 2.1 mg (Janssen Pharmaceuticals, Inc.)(fentanyl D), and was jointly developed by Meiji Seika Pharma Co., Ltd. and Yutoku Pharmaceutical Ind. Co., Ltd. The present study was performed to investigate the safety and pharmacokinetics of fentanyl M in Japanese healthy male subjects when naltrexone was co-administered and to investigate the bioequivalence between fentanyl M and fentanyl D. In this open label, randomized, two-way cross-over study, transdermal fentanyl was applied to the subject's chest (period I: right, period II: left) as a single 72-hour application. We confirmed the safety and pharmacokinetics of fentanyl M in Japanese healthy male subjects co-administered naltrexone, and the bioequivalence between fentanyl D and fentanyl M. Safety was assessed up to 120 hours after a single application of fentanyl tape co-administered with naltrexone, and drug concentrations in serum samples were measured for calculation of pharmacokinetic parameters of fentanyl to determine bioequivalence. The safety and serum concentrations were comparable between fentanyl M and fentanyl D. The mean values of PK parameters (C_max, AUC_0→t, AUC_0→∞, MRT_0→t, MRT_0→∞, k_el, t_max and t_1/2) were comparable between the two products and 90% confidence intervals were within the predefined bioequivalence range. Fentanyl M is expected to have similar efficacy and safety as fentanyl D in patients with cancer pain. (Jpn J Clin Pharmacol Ther 2013; 44(4): 307-312)