PhaseⅠClinical Trial of Xuesaitong Saline Injections in Healthy Volunteers / 中药新药与临床药理

ABSTRACT

Objective To assess the safety and tolerance of single-dose and continuous intravenous drip of Xuesaitong saline injection in Chinese volunteers,thus to establish the effective clinical dosage.Methods Thirty-one healthy volunteers were randomized into 4 single-dose groups(100,200,400 and 600 mg respectively)and a multiple-dose group(400 mg,qd ? 14 d).Subjective symptoms,objective signs,vital signs including blood pressure,heart rate,respiration were observed,and routine blood tests,routine urine tests,hepatic function,renal function,clotting function,electrocardiogram were monitored after medication.Results In the single-dose groups,there were no abnormal findings in the vital signs and the lab examinations 0h,1h,8h,24h after medication.Dizziness without association with Xuesaitong occurring in one volunteers of the 200 mg group.It could subside after taking a rest.In the multiple-dose group,no significant changes were found in the vital signs and the lab examinations 4 d,8 d,12 d,15 d after the first dosing.Rash occurred in 2 volunteers,being considered potentially related to the drug and disappearing in one week.Conclusions Xuesaitong is safe at a dose of 100 ~ 600 mg in a single administration or at a dose of 400 mg once day for 14 days for male or female Chinese volunteers,400 mg being suggested for the clinical use.However,Further studies are needed to evaluate the safety of xuesaitong in the target population and allergic reaction should be observed.