[Translation] Primary objective: To compare the differences in the absorption degree and absorption rate of flurbiprofen gel patch (40 mg/patch) provided by Hainan Celic Pharmaceutical Co., Ltd. and flurbiprofen gel patch (trade name: ZEPOLAS®, specification: 40 mg/patch) certified by Mikasa Pharmaceutical Co., Ltd. in Chinese healthy population under fasting administration conditions using a single-center, randomized, open, two-period crossover, fasting trial design, and evaluate bioequivalence.
Secondary objectives: 1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects; 2) To evaluate the adhesion of the test preparation and the reference preparation during medication in Chinese healthy subjects; 3) To evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.
主要目的:采用单中心、随机、开放、双周期交叉、空腹试验设计,比较空腹给药条件下,海南赛立克药业有限公司提供的氟比洛芬凝胶贴膏(40 mg/贴)与日本三笠制药株式会社持证的氟比洛芬凝胶贴膏(商品名:ZEPOLAS®,规格:40 mg/贴)在中国健康人群中吸收程度和吸收速度的差异,评价生物等效性。
次要目的:1)评价受试制剂与参比制剂在中国健康受试者中的安全性;2)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黏附性;3)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] Primary objective: To compare the differences in the absorption degree and absorption rate of flurbiprofen gel patch (40 mg/patch) provided by Hainan Celic Pharmaceutical Co., Ltd. and flurbiprofen gel patch (trade name: ZEPOLAS®, specification: 40 mg/patch) certified by Mikasa Pharmaceutical Co., Ltd. in Chinese healthy population under fasting administration conditions using a single-center, randomized, open, two-period crossover, fasting trial design, and evaluate bioequivalence.
Secondary objectives: 1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects; 2) To evaluate the adhesion of the test preparation and the reference preparation during medication in Chinese healthy subjects; 3) To evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.