[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of ambroxol hydrochloride tablets in Chinese healthy volunteers under fasting and fed conditions
研究健康受试者空腹及餐后单次口服受试制剂盐酸氨溴索片(山东济坤生物制药有限公司,规格:30mg)与参比制剂盐酸氨溴索片(商品名:Surbronc ®,规格:30mg)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在空腹及餐后状态下给药时的生物等效性,观察受试制剂和参比制剂在健康受试者中的安全性
[Translation] To study whether there are differences in the absorption extent and speed of a single oral administration of the test preparation Ambroxol Hydrochloride Tablets (Shandong Jikun Biopharmaceutical Co., Ltd., specification: 30 mg) and the reference preparation Ambroxol Hydrochloride Tablets (trade name: Surbronc ®, specification: 30 mg) to healthy subjects on an empty stomach or after a meal, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach or after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects