金玉康胶囊Ⅰ期耐受性临床研究

目的:评价健康人体对金玉康胶囊的耐受性和安全性.方法:将40例受试者随机分为单次给药组和连续给药组.单次给药组分别单次口服金玉康胶囊150,300,450,600,750和900mg;连续给药组以750mg·d-1剂量连续服药7d.观察药物的不良反应、实验室检查、心电图以及生命体征.结果:在单次服药150～900mg及750mg·d-1连续服药7d的观察剂量范围内,金玉康胶囊对健康受试者的生命体征和肝肾功能没有明显影响;主要不良反应有困倦、头晕头痛、口干,个别有恶心呕吐.结论:在观察剂量范围内,金玉康胶囊的耐受性和安全性良好.

Phase Ⅰ safety and tolerability study of Jinyukang Capsule

Objective: To assess the safety and tolerance of Jinyukang Capsule in Chinese healthy volunteers. Methods: 40 healthy volunteers were randomized to either single-dose group or multiple-doses group. In the single dose group, subjects randomly received one of the oral dose regimens of 150,300,450,600,750 or 900mg. In the multiple-dose group, subjects orally received 750mg daily for 7 days. The safety profiles and tolerability were evaluated based on vital signs, routine blood and urine tests, hepatic and renal functions, blood electrolytes, and electrocardiogram and incidence of adverse events. Results: No significant changes were found in all laboratory and physical examinations for both groups. Common adverse events included drowsiness, dizziness, headache and dry mouth, nausea and vomiting. Conclusion: Jinyukang capsules showed better safety profile and tolerability in this phase I study.