[Translation] A single-center, open-label, randomized, single-dose, three-period, three-sequence, partially repeated crossover bioequivalence study to evaluate the test preparation azithromycin dry suspension and the reference preparation azithromycin dry suspension (Zithromax®) in healthy adult subjects in the fasting/fed state
以辉瑞制药有限公司持证的阿奇霉素干混悬剂(商品名:希舒美®)为参比制剂,以海南全星制药有限公司生产的阿奇霉素干混悬剂为受试制剂,通过单中心、开放、随机、单剂量、三周期、三序列、部分重复交叉临床研究来评价两种制剂的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The azithromycin dry suspension (trade name: Xishumei®) certified by Pfizer Pharmaceuticals Co., Ltd. was used as the reference preparation, and the azithromycin dry suspension produced by Hainan Quanxing Pharmaceutical Co., Ltd. was used as the test preparation. The human bioequivalence of the two preparations was evaluated through a single-center, open, randomized, single-dose, three-cycle, three-sequence, partially repeated crossover clinical study.
Secondary study purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.