[Translation] To evaluate the single-center, open, randomized, single-center, open-label, single-center, topical use of the test preparation flurbiprofen gel patch (strength: 40mg) and the reference preparation (Zeps®) (strength: 40mg) in healthy adult subjects Dose, two-cycle, two-sequence, double-crossover bioequivalence study.
主要目的:选择氟比洛芬凝胶贴膏(商品名:泽普思,规格:40 mg;日本三笠制药株式会社)为参比制剂,对乐明药业(苏州)有限公司生产的受试制剂氟比洛芬凝胶贴膏(规格:40 mg)进行外用条件下人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在外用条件下的生物等效性。
次要目的:观察中国健康受试者外用受试制剂氟比洛芬凝胶贴膏(规格:40 mg)和参比制剂氟比洛芬凝胶贴膏(商品名:泽普思,规格:40 mg)后的安全性。评估健康志愿受试者在试验期间,外用受试制剂氟比洛芬凝胶贴膏(规格:40 mg)和参比制剂氟比洛芬凝胶贴膏(商品名:泽普思,规格:40 mg)附着力及外用刺激性情况。
[Translation] Main purpose: To select flurbiprofen gel patch (trade name: Zepus, specification: 40 mg; Japan Mikasa Pharmaceutical Co., Ltd.) as the reference preparation, to test the test products produced by Leming Pharmaceutical (Suzhou) Co., Ltd. The preparation flurbiprofen gel patch (specification: 40 mg) was subjected to a human bioequivalence test under external use conditions to compare whether the difference in the absorption rate and extent of the drug in the test preparation and the reference preparation was within an acceptable range Internally, the bioequivalence of the two formulations under topical conditions was evaluated.
Secondary objective: To observe the topical use of the test preparation flurbiprofen gel patch (specification: 40 mg) and the reference preparation flurbiprofen gel patch (trade name: Zepus, specifications: 40 mg). During the test period, healthy volunteers were evaluated for topical application of the test preparation flurbiprofen gel patch (specification: 40 mg) and the reference preparation flurbiprofen gel patch (trade name: Zepus, specifications: 40 mg) adhesion and external irritation.