[Translation] Bioequivalence study of azithromycin granules in single center, randomized, open, single dose, two preparations, two cycles, two sequences, double crossover fasting/fed state in Chinese healthy subjects
主要目的:健康受试者空腹或餐后状态下,单次口服重庆莱美药业股份有限公司生产的受试制剂阿奇霉素颗粒(规格:100mg/袋)或ファイザー株式会社(辉瑞)生产的参比制剂小儿用阿奇霉素细粒剂10%(商品名:希舒美®;规格:100mg:1g),分别考察空腹或餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数,评价两制剂的生物等效性。
次要目的:考察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Under fasting or postprandial conditions, healthy subjects were given a single oral administration of the test preparation azithromycin granules (specification: 100mg/bag) produced by Chongqing Laimei Pharmaceutical Co., Ltd. or the reference drug produced by Faizaer Co., Ltd. (Pfizer). Preparation Azithromycin fine granules for children 10% (trade name: Zithromax®; specification: 100mg: 1g), investigate the pharmacokinetics of the test preparation and the reference preparation in healthy subjects under fasting or postprandial conditions To evaluate the bioequivalence of the two preparations.
Secondary purpose: To investigate the safety of the test preparation and the reference preparation in healthy subjects.