[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence, crossover bioequivalence study of cimetidine tablets in Chinese healthy subjects
主要研究目的:在健康受试者中评估受试制剂上海信谊天平药业有限公司生产的西咪替丁片和参比制剂Medtech Products Inc生产的西咪替丁片(商品名:Tagamet HB®)的生物等效性;
次要研究目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the study is to evaluate the bioequivalence of the test preparation, Cimetidine Tablets produced by Shanghai Xinyi Tianping Pharmaceutical Co., Ltd., and the reference preparation, Cimetidine Tablets (trade name: Tagamet HB®) produced by Medtech Products Inc. in healthy subjects;
The secondary purpose of the study is to observe the safety of the test preparation and the reference preparation in healthy subjects.