[Translation] A randomized, open-label, single-dose, two-formulation, three-sequence, three-period, partially repeated crossover bioequivalence study of a single oral dose of azithromycin dry suspension in healthy subjects after fasting or after meals
主要研究目的: 研究空腹和餐后状态下单次口服受试制剂阿奇霉素干混悬剂(规格:100mg,浙江中同药业有限公司生产和持证)与参比制剂阿奇霉素干混悬剂(希舒美®,规格: 100mg,辉瑞制药有限公司生产和持证)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的: 空腹和餐后状态下,研究单次口服受试制剂阿奇霉素干混悬剂和参比制剂阿奇霉素干混悬剂(希舒美®)在健康成年受试者中的安全性。
[Translation] Main study objectives: To study the pharmacokinetics of the test preparation azithromycin dry suspension (specification: 100 mg, produced and licensed by Zhejiang Zhongtong Pharmaceutical Co., Ltd.) and the reference preparation azithromycin dry suspension (Zithromax®, specification: 100 mg, produced and licensed by Pfizer Pharmaceuticals Co., Ltd.) in healthy adult subjects after single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations in fasting and fed state.
Secondary study objectives: To study the safety of the test preparation azithromycin dry suspension and the reference preparation azithromycin dry suspension (Zithromax®) in healthy adult subjects after single oral administration in fasting and fed state.