阿昔莫司胶囊在中国健康志愿者中空腹/餐后状态下的人体生物等效性试验
[Translation] Human bioequivalence study of acipimox capsules in Chinese healthy volunteers under fasting/fed conditions
主要研究目的:
有关生物等效性试验的规定,选择Pfizer Limited为持证商的阿昔莫司胶囊(商品名:OLBETAM,规格:0.25g)为参比制剂,对四川豪运药业股份有限公司生产并提供的受试制剂阿昔莫司胶囊(规格:0.25g)进行空腹和餐后给药条件下的人体生物等效性试验,比较受试制剂与参比制剂的药代动力学特征,评价两种制剂在空腹或餐后给药条件下的生物等效性。
次要研究目的:
观察健康受试者口服受试制剂阿昔莫司胶囊(规格:0.25g)和参比制剂阿昔莫司胶囊(商品名:OLBETAM,规格:0.25g)的安全性。
[Translation] Main study purpose:
According to the regulations on bioequivalence test, Acipimox Capsules (trade name: OLBETAM, specification: 0.25g) of which Pfizer Limited is the licensee was selected as the reference preparation. The human bioequivalence test of the test preparation Acipimox Capsules (specification: 0.25g) produced and provided by Sichuan Haoyun Pharmaceutical Co., Ltd. was conducted under fasting and postprandial administration conditions, and the pharmacokinetic characteristics of the test preparation and the reference preparation were compared to evaluate the bioequivalence of the two preparations under fasting or postprandial administration conditions.
Secondary study purpose:
Observe the safety of oral administration of the test preparation Acipimox Capsules (specification: 0.25g) and the reference preparation Acipimox Capsules (trade name: OLBETAM, specification: 0.25g) to healthy subjects.
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