盐酸丙卡特罗片在空腹及餐后条件下的人体生物等效性试验。
[Translation] Bioequivalence study of Procaterol hydrochloride tablets in humans under fasting and fed conditions.
主要研究目的:考察空腹及餐后条件下,健康受试者单次口服由南京集萃剂鼎医药有限公司提供的盐酸丙卡特罗片(受试制剂T,规格:25μg)与单次口服由OTSUKA PHARMACEUTICAL Co., Ltd持证的盐酸丙卡特罗片(参比制剂R,商品名:Meptin-mini®,规格:25μg)的药动学特征,评价两制剂的生物等效性,为该受试制剂注册申请提供依据。
次要研究目的:观察健康受试者在空腹及餐后条件下单次口服2片受试制剂盐酸丙卡特罗片(规格:25μg)与2片参比制剂盐酸丙卡特罗片(商品名:Meptin-mini®,规格:25μg)的安全性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of a single oral administration of Procaterol Hydrochloride Tablets (test preparation T, specification: 25μg) provided by Nanjing Jicui Jiding Pharmaceutical Co., Ltd. and a single oral administration of Procaterol Hydrochloride Tablets (reference preparation R, trade name: Meptin-mini®, specification: 25μg) certified by OTSUKA PHARMACEUTICAL Co., Ltd. in healthy subjects under fasting and postprandial conditions, to evaluate the bioequivalence of the two preparations, and to provide a basis for the registration application of the test preparation.
Secondary purpose of the study is to observe the safety of a single oral administration of 2 tablets of the test preparation Procaterol Hydrochloride Tablets (specification: 25μg) and 2 tablets of the reference preparation Procaterol Hydrochloride Tablets (trade name: Meptin-mini®, specification: 25μg) in healthy subjects under fasting and postprandial conditions.
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