[Translation] Preliminary bioequivalence study of generic drug Procaterol Hydrochloride Granules and original drug Procaterol Hydrochloride Granules (Meptin®) in Chinese healthy subjects under fasting and postprandial conditions
主要试验目的:以四川大冢制药有限公司生产的盐酸丙卡特罗颗粒(规格:0.01%,50 g/瓶)为受试制剂,按生物等效性研究的有关规定,以Otsuka Pharmaceutical Co.,Ltd.生产的盐酸丙卡特罗颗粒(规格:0.01%,100 g/瓶,商品名:Meptin®)为参比制剂,考察两种制剂在空腹及餐后条件下的相对生物利用度,对受试制剂和参比制剂的生物等效性进行初步评价,为临床用药正式试验提供参考数据。
次要试验目的:评估盐酸丙卡特罗颗粒相比参比制剂在健康受试者中的安全性和耐受性。
[Translation] The main purpose of the test: Procaterol hydrochloride granules (specification: 0.01%, 50 g/bottle) produced by Sichuan Otsuka Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence research, Otsuka Pharmaceutical Co., Procaterol hydrochloride granules (specification: 0.01%, 100 g/bottle, trade name: Meptin®) produced by Ltd. was used as a reference preparation, and the relative bioavailability of the two preparations under fasting and postprandial conditions was investigated. Preliminary evaluation of the bioequivalence of the test preparation and the reference preparation to provide reference data for formal trials of clinical medication.
Secondary purpose: To evaluate the safety and tolerability of Procaterol Hydrochloride Granules compared to the reference formulation in healthy subjects.