[Translation] A randomized, open-label, two-formulation, single-dose, two-period, double-crossover bioequivalence study of ambroxol hydrochloride anhydrous swallow granules in healthy volunteers under fasting and fed conditions
主要目的1:以山东科成医药科技有限公司持有的盐酸氨溴索无水吞服颗粒(15 mg)为试验药,与Sanofi-Aventis France公司生产的盐酸氨溴索片(30 mg)(商品名:Surbronc®)为对照药,考察餐后和空腹条件下试验药与对照药在健康受试者中的药代动力学参数,评价两制剂的生物等效性。.
主要目的2:对试验药无水吞服颗粒剂型口感评价评估。
次要目的:观察试验药和对照药在中国健康受试者中的安全性。
[Translation] Main purpose 1: Using the anhydrous swallowable granules (15 mg) of ambroxol hydrochloride held by Shandong Kecheng Pharmaceutical Technology Co., Ltd. as the test drug and the ambroxol hydrochloride tablets (30 mg) (trade name: Surbronc®) produced by Sanofi-Aventis France as the control drug, the pharmacokinetic parameters of the test drug and the control drug in healthy subjects under fed and fasting conditions were investigated to evaluate the bioequivalence of the two preparations. .
Main purpose 2: Evaluation of the mouthfeel of the anhydrous swallowable granules of the test drug.
Secondary purpose: Observe the safety of the test drug and the control drug in healthy Chinese subjects.