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.