[Translation] A single-center, randomized, open-label, single (fasting/postprandial) oral administration, two-agent, two-sequence, two-cycle, crossover human bioequivalence trial of azithromycin tablets in healthy Chinese subjects
"主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂阿奇霉素片(规格:0.5g;生产企业:山西同达药业有限公司)和参比制剂阿奇霉素片(商品名:Sumamed/舒美特;规格:500mg;持证商:Pliva Croatia Ltd.)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂阿奇霉素片和参比制剂阿奇霉素片(Sumamed/舒美特)在中国健康受试者中的安全性。"
[Translation] "Main purpose: To observe the test preparation Azithromycin Tablets (specification: 0.5g; manufacturer: Shanxi Tongda Pharmaceutical Co., Ltd.) and the reference preparation Azithromycin Tablets (commodity) in Chinese healthy subjects in a fasting/postprandial state. Name: Sumamed/Summet; Strength: 500mg; Licensee: Pliva Croatia Ltd.), the pharmacokinetic characteristics of the two preparations in the fasting/postprandial state were evaluated.
Secondary objective: To observe the safety of the test preparation Azithromycin Tablets and the reference preparation Azithromycin Tablets (Sumamed/Summed) in healthy Chinese subjects. "