[Translation] A randomized, open-label, two-dose, single-dose, two-cycle, double-crossover, fasting and postprandial bioequivalence trial of ambroxol hydrochloride swallowed granules in healthy subjects
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: Take Ambroxol Hydrochloride Anhydrous Swallow Granules (15 mg) held by Shandong Kecheng Pharmaceutical Technology Co., Ltd. as the test drug, and ambroxol Hydrochloride Tablets (30 mg) ( Trade name: Surbronc®) is the reference drug. The pharmacokinetic parameters of the test drug and the reference drug in healthy subjects under postprandial and fasting conditions were investigated to evaluate the bioequivalence of the two preparations. .
Main purpose 2: To evaluate the mouthfeel of the test drug anhydrous swallow granules.
Secondary objective: To observe the safety of the experimental drug and the reference drug in healthy Chinese subjects.