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] Human bioequivalence test of Procaterol Hydrochloride Tablets under fasting and postprandial 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] Main research purpose: To investigate whether healthy subjects take a single oral administration of Procaterol Hydrochloride Tablets (test preparation T, specification: 25 μg) provided by Nanjing Jizhujiding Pharmaceutical Co., Ltd. and a single oral administration of OTSUKA under fasting and postprandial conditions. Pharmacokinetic characteristics of procaterol hydrochloride tablets (reference preparation R, trade name: Meptin-mini®, specification: 25 μg) certified by PHARMACEUTICAL Co., Ltd., to evaluate the bioequivalence of the two preparations, this subject Provide basis for preparation registration application.
Secondary research purpose: To observe the oral administration of 2 tablets of the test preparation Procaterol Hydrochloride Tablets (specification: 25 μg) and 2 tablets of the reference preparation Procaterol Hydrochloride Tablets (trade name: Meptin-mini®, strength: 25μg) safety.
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