[Translation] A randomized, open-label, three-period, partially replicated, crossover bioequivalence study of a single oral dose of 500 mg of the test formulation clarithromycin extended-release tablets and the reference formulation clarithromycin extended-release tablets (Klacid SR®, licensee: Mylan Healthcare B.V.) in healthy volunteers under fasting and fed conditions
主要目的:在中国健康受试者中评价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:Mylan Healthcare B.V.,500mg)的人体生物等效性。
次要目的:观察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.
Secondary objective: To observe the safety of the test preparation and reference preparation of clarithromycin extended-release tablets in healthy Chinese subjects.