[Translation] A randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of azithromycin capsules (0.25g) under fasting conditions in healthy Chinese subjects
主要研究目的:按有关生物等效性试验的规定,选择普利瓦克罗地亚有限公司为生产商的阿奇霉素胶囊为参比制剂,对西安利君制药有限责任公司生产的受试制剂阿奇霉素胶囊进行空腹给药人体生物等效性试验。 次要研究目的:观察健康志愿受试者口服受试制剂阿奇霉素胶囊和参比制剂阿奇霉素胶囊的安全性。
[Translation] Main research purpose: According to the relevant bioequivalence test regulations, select azithromycin capsules produced by Priva Croatia Co., Ltd. as the reference preparation, and give the test preparation azithromycin capsules produced by Xi'an Lijun Pharmaceutical Co., Ltd. on an empty stomach. Human bioequivalence test. Secondary research objectives: To observe the safety of oral administration of test preparation azithromycin capsules and reference preparation azithromycin capsules in healthy volunteers.