冬青通脉胶囊Ⅰ期临床人体耐受性研究

PhaseⅠclinical tolerable study of Dongqing Tongmai Capsula on human

目的选择健康志愿者口服不同剂量的冬青通脉胶囊,考察人体的耐受性和安全性,并为Ⅱ期临床试验提供安全的剂量范围。方法将筛选合格的44名健康受试者,按从低到高的顺序口服一个剂量的试药,而后进行连续给药耐受性试验。结果单次给药组受试者出现肌酐、血尿素氮轻度升高,尿蛋白阳性等与药物有关的实验室指标异常。连续给药组未发现与药物有关的实验室指标异常。结论总体来说,当一次用药不超过3粒(0.75g),或连续给药不超过每次2粒、每天3次(1.5g),在人体应用冬青通脉胶囊是安全的。

Objective In order to observe the tolerance and safety of human body, healthy volunteers were selected to take orally Dongqing Tongrnai Capsula at different doses, and the safe dosage range in phase II clinical trials were provided. Methods 44 healthy volunteers took orally the drug of one of 4 different dosages increasing by degree, and then continous-dose tolerance test was carried out. Results Abnormal laboratory indicators associated with the tested drug, such as slight increment of creatinine, urea nitrogen, and positive urine protein appeared in single-dose group, while abnormal indicator was not detected in continous-dose group. Conclusion Overall, single-dose less than 3 pills （as much as 0.75 g） or continous-dose less than 2 pills Tid （as much as 1.5 g） Dongqing Tongmai Capsula could be safe for human body.