[Translation] A single-center, randomized, open-label, single-dose, two-preparation, two-cycle, double-crossover fasting and postprandial bioequivalence trial of Procaterol Hydrochloride Granules in healthy subjects
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:
Procaterol hydrochloride granules produced by Jiangsu Changjiang Pharmaceutical Co., Ltd. entrusted by Shijiazhuang Rongwudi Pharmaceutical Technology Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence testing, propylene hydrochloride hydrochloride produced by OTSUKA PHARMACEUTICAL Co., Ltd. was used as the test preparation. Catrol Granules (trade name: Meptin®) is a reference preparation to compare the absorption rate and pharmacokinetic characteristics of the absorption degree in healthy Chinese adult subjects under fasting and postprandial administration conditions. Differences in the extent and rate of absorption among human populations to evaluate the bioequivalence of two formulations.
Secondary purpose:
To 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 Chinese healthy adult subjects under fasting and postprandial conditions.