日本人健康成人男性を対象としたフェンタニル1日用テープの麻薬拮抗薬非併用下における生物学的同等性試験

抄録

FENTANYL Tape for 1 Day ⌈MEIJI⌋ is a generic drug of OneDuro^® Patch (Janssen Pharmaceutical K.K.) under development by Meiji Seika Pharma Co., Ltd. and Yutoku Pharmaceutical Ind. Co., Ltd. The generic drug contains the same active ingredient fentanyl at the same dose in the same dosage form (transdermal absorption) as the original drug. In this study, 32 healthy male Japanese adults were recruited as subjects. Each subject applied a FENTANYL Tape for 1 Day 0.84 mg ⌈MEIJI⌋ and a OneDuro^® Patch 0.84 mg once in a crossover manner, without concomitant use of antinarcotic. Bioequivalence of these drugs was investigated by analyzing pharmacokinetic parameters (C_max and AUC_0→t) as primary endpoints calculated from serum fentanyl concentration profiles in all 32 subjects. The results confirmed bioequivalence of the two products. Secondary endpoints including pharmacokinetic parameters such as AUC_0→∞, MRT_t and k_el also supported bioequivalence of the two products. When a FENTANYL Tape for 1 Day 0.84 mg ⌈MEIJI⌋ or a OneDuro^® Patch 0.84 mg was applied once for 24 hours without concomitant use of antinarcotic, there were no adverse events such as cutaneous reactions at the application site.