Phase I Clinical Tolerance Study of Tongshuanjiuxin Tablet in Healthy Volunteers

Objective To evaluate the tolerance and safety of Tongshuanjiuxin tablet in healthy volunteers,and assess the safety range of its clinical use in phase Ⅱ clinical trial.Methods Between January and April 2009,38 healthy volunteers were randomly divided into five single-dose groups(3,6,8,10,and 15 tablets respectively) and a continuousdose group(2 or 3 tablets per time,three times a day,for seven days).The safety profile and tolerance were evaluated by observing vital signs,laboratory test results,clinical symptoms and adverse reactions.Results Mi1d adverse reactions such as slight headache,dizziness or nausea,appeared in continuous-dose group and single-dose group(8,15 tablets,each group had one case of mild adverse reaction).All these reactions were relieved automatically.Conclusions Healthy body has a good tolerance for Tongshuanjiuxin tablet,and it is safe to use this drug except slight headache or nausea.The recommended dose is 2 tablets or 3 tablets per time,three times a day in phase Ⅱ clinical tria1.