脑络泰注射液Ⅰ期临床耐受性试验

Phase Ⅰ trial on human tolerability of Naoluotai Injection

目的:观察健康受试者单次和连续静脉滴注脑络泰注射液的耐受性和安全性,为Ⅱ期临床试验给药提供安全的药物剂量范围。方法:筛选36名健康受试者,分别用单次及连续给药观察该药的安全性和耐受性。结果:单次给药和多次给药均未出现不良反应。结论:健康人体对脑络泰注射液的耐受性较好,临床使用比较安全。推荐的Ⅱ期临床试验剂量为不超过20mL,每日1次。

Objective：It is to observe the tolerance and safety for health volunteers after being injected Naoluotai Injection once or continuously, so as to assess and provide the safety range for clinic use of drugs for phase Ⅱ.Methods：Selecting 36 health volunteers to observe the tolerance and safty with injection once or continuously, respectively.Results：Neither once nor continuous injection appeared adverse reaction.Conclusion：Health body has a good tolerance for Naoluotai Injection, and it is safe to use this drug.The recommended dose is 20 mL once per day in phase Ⅱ in clinical trial.