[Translation] An open, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the efficacy of ambroxol hydrochloride dispersible tablets 30 mg in healthy adults on a fasting/fed diet
主要研究目的
评估烟台东诚大洋制药有限公司生产的盐酸氨溴索分散片(规格:30mg)与BOEHRINGER INGELHEIM FRANCE持证,DELPHARM REIMS生产的盐酸氨溴索片(SURBRONC® EXPECTORANT,规格:30mg)在健康受试者中空腹和餐后状态下的生物等效性试验。
次要研究目的
观察受试制剂盐酸氨溴索分散片在健康受试者中的安全性。
[Translation] Main study objectives
To evaluate the bioequivalence of Ambroxol Hydrochloride Dispersible Tablets (Specification: 30mg) produced by Yantai Dongcheng Dayang Pharmaceutical Co., Ltd. and Ambroxol Hydrochloride Tablets (SURBRONC® EXPECTORANT, Specification: 30mg) produced by BOEHRINGER INGELHEIM FRANCE and DELPHARM REIMS in healthy subjects under fasting and fed conditions.
Secondary study objectives
To observe the safety of the test preparation Ambroxol Hydrochloride Dispersible Tablets in healthy subjects.