[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, crossover, fed-state bioequivalence study of clarithromycin extended-release tablets in healthy volunteers
主要目的:在中国健康受试者中评价餐后条件下浙江普利药业有限公司生产的克拉霉素缓释片(受试制剂,500mg)与欧盟上市克拉霉素缓释片(参比制剂,Klacid®SR,持证商:MylanHealthcareB.V.,500mg)的人体生物等效性。次要目的:观察餐后条件下克拉霉素缓释片受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of clarithromycin extended-release tablets (test preparation, 500 mg) produced by Zhejiang Puli Pharmaceutical Co., Ltd. and clarithromycin extended-release tablets (reference preparation, Klacid® SR, licensee: Mylan Healthcare B.V., 500 mg) marketed in the EU in healthy Chinese subjects under fed conditions. Secondary objective: To observe the safety of clarithromycin extended-release tablets test preparation and reference preparation in healthy Chinese subjects under fed conditions.