[Translation] A single-center, randomized, open-label, fasting, single-dose, two-formulation, two-sequence, two-period, two-crossover bioequivalence study of flurbiprofen patches in healthy adult participants in China.
主要研究目的:
考察空腹单次外用受试制剂氟比洛芬贴剂(规格:每贴10cm×14cm,含氟比洛芬40mg,北京百奥药业有限责任公司生产,北京百奥药业有限责任公司提供)与参比制剂氟比洛芬贴剂(商品名:Zepolas ®,规格:每贴10cm×14cm,含氟比洛芬40mg,三笠制药株式会社持证生产,北京百奥药业有限责任公司提供)在中国成年健康试验参与者体内的药代动力学特征,评价空腹状态下外用两种制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价受试制剂和参比制剂空腹单次贴敷在中国成年健康试验参与者中的安全性;
评价受试制剂与参比制剂在中国健康试验参与者用药过程中的黏附性;
评价受试制剂与参比制剂对中国健康试验参与者的皮肤反应性。
[Translation] Primary Objective: To investigate the pharmacokinetic characteristics of the test formulation flurbiprofen patch (10cm x 14cm, containing 40mg flurbiprofen, manufactured and supplied by Beijing Bio-Pharmaceutical Co., Ltd.) and the reference formulation flurbiprofen patch (trade name: Zepolas®, 10cm x 14cm, containing 40mg flurbiprofen, licensed by Mikasa Pharmaceutical Co., Ltd., and supplied by Beijing Bio-Pharmaceutical Co., Ltd.) in healthy adult participants in a Chinese trial, evaluating their bioequivalence under fasting conditions, and providing a reference for the drug's application and clinical use.
Secondary Objectives: To evaluate the safety of the test and reference formulations under fasting single-dose application in healthy adult participants in a Chinese trial; to evaluate the adhesion of the test and reference formulations during administration in healthy participants in a Chinese trial; and to evaluate the skin reactivity of the test and reference formulations in healthy participants in a Chinese trial.