健脑康胶囊人体耐受性试验

Tolerance study of Jiannaokang capsule in healthy volumteers

目的评估健康志愿者口服健脑康胶囊后的安全性。方法共32名志愿者依注册顺序分组,安慰剂对照,双盲服药。18名健康志愿者分5个剂量组分别单次口服健脑康胶囊;14名健康志愿者分2个剂量连续7d口服健脑康胶囊。结果18名单次口服试验者给药后24 h体格检查、生命体征检查未见异常,其中300 mg组(>临床推荐剂量4倍)、375 mg组(>临床推荐剂量5倍)各有1名受试者发生轻度的心电图变异,375 mg组2名受试者有轻度头痛和胃部不适。14名多剂量组受试者连续服药后未发生与健脑康胶囊相关的不良事件。结论健康人体口服健脑康胶囊剂量应低于每次225mg安全性良好。

AIM To assess the safety and toleration of Jianaokang capsule in Chinese healthy male volunteers after oral administration. METHODS A double-blinded and negative-controlled clinical trial was carried out, in which 32 volunteers were divided into the corresponding groups according to the sequence enrolled. Eighteen healthy volunteers divided into 5 single dose groups were administered Jiannaokang capsule orally, and 14 healthy volunteers divided into 2-dose groups were administered Jiannaokang capsule orally in 7 consecutive days. RESULTS There was no abnormal of medical examination and signs checks in the 18 volunteers 24 h after a single oral administration. There was one volunteers in 300 mg group （4 times as the clinical recommended dose） and one in 375 mg group （5 times as the clinical recommended dose） appeared mild electrocardiogram variation. And there were two volunteers in 375 mg group had mild headaches and stomach discomfort. There were no related adverse events among the 14 volunteers after administration with Jiannaokang capsule in 7 consecutive days. CONCLUSION It is safe for healthy volunteers to singly take Jiannaokang capsule below 225 mg.