[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of ambroxol hydrochloride tablets (30 mg) in healthy volunteers under fasting and fed conditions
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] To study the relative bioavailability of ambroxol hydrochloride tablets (test preparation, 30 mg) produced by Beijing Taiyang Pharmaceutical Co., Ltd. and ambroxol hydrochloride tablets (reference preparation, 30 mg, trade name: SURBRONC) produced by Boehringer Ingelheim France in healthy subjects under fasting and fed conditions after a single oral administration, to evaluate the bioequivalence between the test preparation and the reference preparation, and to provide a basis for process optimization and clinical use of the test preparation.