[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, double-crossover bioequivalence study of Procaterol Hydrochloride Granules in healthy subjects under fasting and fed conditions
主要目的:
以石家庄荣雾迪医药科技有限公司委托江苏长江药业有限公司生产的盐酸丙卡特罗颗粒为受试制剂,按生物等效性试验的有关规定,以OTSUKA PHARMACEUTICAL Co.,Ltd.生产的盐酸丙卡特罗颗粒(商品名:Meptin®)为参比制剂,对比在中国健康成年受试者中空腹及餐后给药条件下人体内的吸收速度及吸收程度药代动力学特征,比较在健康成年人群中吸收程度和速度的差异,评价两种制剂的生物等效性。
次要目的:
观察评估空腹和餐后状态条件下单次口服受试制剂盐酸丙卡特罗颗粒和参比制剂盐酸丙卡特罗颗粒(商品名:Meptin®)在中国健康受试者成年人群中的安全性。
[Translation] Main purpose:
Using Procaterol Hydrochloride Granules produced by Jiangsu Changjiang Pharmaceutical Co., Ltd. commissioned by Shijiazhuang Rongwudi Pharmaceutical Technology Co., Ltd. as the test preparation, and Procaterol Hydrochloride Granules (trade name: Meptin®) produced by OTSUKA PHARMACEUTICAL Co., Ltd. as the reference preparation according to the relevant provisions of the bioequivalence test, the pharmacokinetic characteristics of absorption rate and absorption degree in the human body under fasting and postprandial administration conditions in healthy adult subjects in China were compared, the differences in absorption degree and rate in healthy adult population were compared, and the bioequivalence of the two preparations was evaluated.
Secondary purpose:
Observe and evaluate the safety of a single oral dose of the test preparation Procaterol Hydrochloride Granules and the reference preparation Procaterol Hydrochloride Granules (trade name: Meptin®) in healthy adult subjects in China under fasting and postprandial conditions.