胡黄胶囊Ⅰ期临床人体耐受性试验

Phase Ⅰ clinical tolerance study of Huhuang capsule(胡黄胶囊) in healthy volunteers

目的:评价健康受试者对胡黄胶囊的耐受性和安全性,为Ⅱ期临床试验给药方案提供依据。方法:选择健康受试者44例,随机进入7个单次给药组和2个连续给药组。单次给药组分别口服胡黄胶囊100mg、200mg、300mg、500mg、700mg、900mg、1200mg,连续给药组口服胡黄胶囊200mg/次和300mg/次,3次/天,服药10天。观察生命体征、实验室检查指标、临床症状和不良反应,仅见轻微腹泻。结果:单次给药500mg剂量组及连续给药剂量组有轻度不良反应。结论:健康人体对胡黄胶囊耐受性较好,临床应用比较安全,推荐Ⅱ期临床试验的剂量为100mg～200mg/次,1天3次。

Objective：To evaluate the tolerance and safety of Huhuang capsules in healthy volunteers,and assess the safety range of clinical use of drugs and given-drug project in phase Ⅱ clinical trial.Methods： A total of 44 healthy volunteers were randomly divided into 7 single-dose groups（100mg,200mg,300 mg,500 mg,700 mg,900 mg and 1200mg）and a multiple-dose group（200mg and 300 mg,3 times a day,for 10 days）.The safety profile and tolerance were evaluated by observing vital signs,laboratory tests clnical symptoms and adverse reaction.Results： Mi1d adverse reaction appeared when given the drug of one dose more than 500mg and successive dose.Conclusion ： Healthy body has a good tolerance for Huhuang capsule,and it is safe to use this drug except slight diarrhea.The recommended dose is 200mg～300mg 3 times every day in phase Ⅱclinical tria1.