[Translation] Main purpose: Using a single-center, randomized, open, two-period crossover, fasting trial design, compare the flurbiprofen gel patch (40 mg/paste) provided by Hainan Celec Pharmaceutical Co., Ltd. under the condition of fasting administration To evaluate the bioequivalence of the difference in absorption degree and absorption speed between flurbiprofen gel patch (trade name: ZEPOLAS®, specification: 40 mg/patch) licensed by Mikasa Pharmaceutical Co., Ltd. in Chinese healthy population.
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 in Chinese healthy subjects; 3) To evaluate the skin reactivity of the test preparation and the reference preparation on 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] Main purpose: Using a single-center, randomized, open, two-period crossover, fasting trial design, compare the flurbiprofen gel patch (40 mg/paste) provided by Hainan Celec Pharmaceutical Co., Ltd. under the condition of fasting administration To evaluate the bioequivalence of the difference in absorption degree and absorption speed between flurbiprofen gel patch (trade name: ZEPOLAS®, specification: 40 mg/patch) licensed by Mikasa Pharmaceutical Co., Ltd. in Chinese healthy population.
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 in Chinese healthy subjects; 3) To evaluate the skin reactivity of the test preparation and the reference preparation on Chinese healthy subjects.