[Translation] A randomized, open-label, two-cycle, two-crossover bioequivalence trial of ambroxol hydrochloride tablets (30 mg) in fasting and postprandial states
研究健康受试者在空腹及进餐后状态下,单次口服由北京太洋药业股份有限公司生产的盐酸氨溴索片(受试制剂,30mg)和Boehringer Ingelheim France(法国勃林格殷格翰制药公司)生产的盐酸氨溴索片(参比制剂,30mg,商品名:SURBRONC)的相对生物利用度,评价受试制剂与参比制剂间的生物等效性,并为受试制剂的工艺优化和临床用药提供依据。
[Translation] Study healthy subjects took a single oral dose of ambroxol hydrochloride tablets (test preparation, 30 mg) and Boehringer Ingelheim France (Boehringer Ingelheim France) produced by Beijing Taiyang Pharmaceutical Co., Ltd. The relative bioavailability of ambroxol hydrochloride tablets (reference preparation, 30 mg, trade name: SURBRONC) produced by the company), evaluate the bioequivalence between the test preparation and the reference preparation, and optimize the process of the test preparation and clinical medicine to provide the basis.