/ CompletedNot Applicable [Translation] Study on the bioequivalence of loxoprofen sodium patch in healthy volunteers
主要目的:采用单中心、随机、开放、两制剂、两序列、双周期交叉、单剂量给药的试验设计,比较空腹给药条件下,内蒙古白医制药股份有限公司提供的洛索洛芬钠贴剂(规格:100 mg/贴(10 cm×14 cm);受试制剂T)与Lead Chemical Co., Ltd持证的洛索洛芬钠贴剂(规格:100 mg/贴(10 cm×14 cm);参比制剂R)在中国健康人群中吸收程度和吸收速度的差异。
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刺激性。
[Translation] Primary objective: To compare the differences in absorption degree and absorption rate of loxoprofen sodium patch (specification: 100 mg/patch (10 cm×14 cm); test preparation T) provided by Inner Mongolia Baiyi Pharmaceutical Co., Ltd. and loxoprofen sodium patch (specification: 100 mg/patch (10 cm×14 cm); reference preparation R) certified by Lead Chemical Co., Ltd. in Chinese healthy population under fasting conditions using a single-center, randomized, open, two-preparation, two-sequence, two-period crossover, single-dose administration trial design.
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 irritation of the test preparation and the reference preparation to Chinese healthy subjects.
100 Clinical Results associated with Inner Mongolia Baiyi Pharmaceutical Co., Ltd.
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