关键词: 开郁宁, 耐受性, 安全性

Abstract: AIM: To assess tolerance of kaiyuning tablet in healthy Chinese volunteers. METHODS: 28 volunteers were enrolled in a single-dose clinical trial for tolerance study which were randomly divided into 6 groups, including 150, 300, 500, 750, 1 000, 1 250 mg/dosing groups.Another 12 volunteers, randomly divided into two groups of 1 000 and 1 250 mg per day, were enrolled in the multiple-dose clinical trial for 7 consective days.Comparisons were conducted with regard to the clinical symptoms, vital signs and lab examinations acquired before and after dosing in the single-dose and multiple-dose regimens, respectively. RESULTS: No severe adverse events were found in the trial.Common adverse events assiociated with Kaiyuning tablet within the dose range from 150 mg to 1 250 mg including:hypertension, hypotension, dizzinese, drowsinese, headache, facial blushing, dry mouth, nausea, stomachache, constipation, diarrhea, numble in the fingers, transaminase elevation and abnomal ECG.These adverse events were slight and tolerable, which recovered spontaneously following drug discontinuation. CONCLUSION: The results suggest that kaiyuning tablet was safe and tolerable at the dose from 150 to 1 250 mg per day.

Key words: kaiyuning tablet, tolerance, safety