[Translation] A randomized, open-label, three-period crossover, multiple-dose comparison of the pharmacokinetics of amoxicillin-ambroxol tablets, amoxicillin tablets, and ambroxol hydrochloride tablets (two drugs used alone)
本试验旨在研究北京国联诚辉医药技术有限公司研制、生产的阿莫西林氨溴索片(每片含阿莫西林250mg和盐酸氨溴索15mg)与单用一种制剂(阿莫西林片或盐酸氨溴索片)的健康人体比较药动学,以提供阿莫西林与氨溴索在健康人体内相互影响与否的药动学数据,为该药的组方设计是否合理提供临床试验依据,为该药进行Ⅱ期临床研究提供依据。
[Translation] The purpose of this study is to study the pharmacokinetics of amoxicillin and ambroxol tablets (each tablet contains 250 mg amoxicillin and 15 mg ambroxol hydrochloride) developed and produced by Beijing Guolian Chenghui Pharmaceutical Technology Co., Ltd. and a single preparation (amoxicillin tablets or ambroxol hydrochloride tablets) in healthy humans, so as to provide pharmacokinetic data on whether amoxicillin and ambroxol affect each other in healthy humans, provide clinical trial basis for whether the formulation design of the drug is reasonable, and provide basis for conducting phase II clinical research on the drug.