[Translation] A single-center, randomized, open-label, fasting, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of flurbiprofen patch in healthy adult Chinese subjects
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10 cm×14 cm,含氟比洛芬40 mg,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10 cm×14 cm,含氟比洛芬40 mg,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)在中国成年健康受试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受试者中的安全性;
评价受试制剂与参比制剂在中国健康受试者用药过程中的粘附性;
评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of the single-application test preparation flurbiprofen patch (specification: 10 cm×14 cm per patch, containing 40 mg flurbiprofen, produced by Beijing Biopharma Co., Ltd. and provided by Beijing Biopharma Co., Ltd.) and the reference preparation flurbiprofen patch (trade name: Zepolas ®, specification: 10 cm×14 cm per patch, containing 40 mg flurbiprofen, produced with a license by Mikasa Pharmaceutical Co., Ltd. and provided by Beijing Biopharma Co., Ltd.) in Chinese healthy adult subjects, to evaluate the bioequivalence of the two preparations for topical use under fasting conditions, and to provide a reference for the application and clinical use of the drug.
Secondary study objectives:
To evaluate the safety of the single-application of the test preparation and the reference preparation on fasting in healthy Chinese adult subjects;
To evaluate the adhesion of the test preparation and the reference preparation during the medication process in healthy Chinese subjects;
To evaluate the skin reactivity of the test preparation and the reference preparation to healthy Chinese subjects.