[Translation] A single-center, randomized, open-label, single-dose, two-preparation, two-sequence, four-cycle, completely repeated crossover bioequivalence study of azithromycin dry suspension in healthy subjects under fasting conditions
主要目的:按生物等效性试验的相关规定,以四川制药制剂有限公司生产的阿奇霉素干混悬剂(0.1g/袋)为受试制剂,以辉瑞制药有限公司生产的阿奇霉素干混悬剂(0.1g/袋,商品名:希舒美®)为参比制剂,比较阿奇霉素干混悬剂在中国健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:评价中国健康受试者空腹口服阿奇霉素干混悬剂受试制剂和参比制剂后的安全性。
[Translation] Main purpose: According to the relevant provisions of bioequivalence test, the azithromycin dry suspension (0.1g/bag) produced by Sichuan Pharmaceutical Preparation Co., Ltd. was used as the test preparation, and the azithromycin dry suspension (0.1g/bag, trade name: Xishumei®) produced by Pfizer Pharmaceutical Co., Ltd. was used as the reference preparation to compare the pharmacokinetic behavior of azithromycin dry suspension in healthy Chinese subjects and evaluate the bioequivalence of the two preparations.
Secondary purpose: To evaluate the safety of the azithromycin dry suspension test preparation and reference preparation after oral administration on an empty stomach in healthy Chinese subjects.