Tolerance study of kaiyuning tablet in healthy Chinese volunteers

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 1250 mg per day.