[Translation] Randomized, open-label, single-dose, two-preparation, two-cycle, two-sequence, crossover design bioequivalence trial of roxithromycin dispersible tablets in healthy subjects under fasting state
主要目的:评价健康受试者在空腹状态下口服天津梅花生物医药科技有限公司生产的受试制剂罗红霉素分散片与Opella Healthcare International SAS生产的参比制剂罗红霉素片(罗力得®)后是否具有生物等效性。
次要目的:观察受试制剂罗红霉素分散片与参比制剂罗红霉素片(罗力得®)在健康受试者中的安全性。
[Translation] Main purpose: To evaluate the oral administration of the test preparation roxithromycin dispersible tablets produced by Tianjin Meihua Biomedical Technology Co., Ltd. and the reference preparation roxithromycin tablets (Rolide) produced by Opella Healthcare International SAS to healthy subjects in the fasting state. ®) is bioequivalent.
Secondary purpose: To observe the safety of the test preparation Roxithromycin Dispersible Tablets and the reference preparation Roxithromycin Tablets (Rolide®) in healthy subjects.