阿克他利人体耐受性试验研究

The study of the tolerance test of actar it to human being

目的 研究正常国人对阿克他利 (Actarit,Acta)的耐受性程度 ,为Ⅱ期临床试验提供安全有效给药方案。方法 选择 2 6名健康志愿者 ,男 13人 ,女 13人 ,按男女分层随机分成 5组 ,每组男女各半 ,每组人数分别为 4,4,6 ,6 ,和 6人 ,按从低到高递增的顺序 10 0 ,2 0 0 ,40 0 ,6 0 0 ,和 80 0mg ,单次口服阿克他利 ,观察给药前 ,给药后 1h和 2 4h的呼吸、心率、体温、血压、心电图及各种不良反应和试验前后的的血尿常规及肝肾功能。结果 阿克他利 (10 0～ 80 0mg)各剂量组试验中 ,志愿者均无明显不良反应 ,试验前后呼吸、心率、体温、血压、心电图等均正常 ,血尿常规及肝肾功能无显著性变化。结论 2 6名健康志愿者口服 (10 0～ 80 0mg)阿克他利均能很好地耐受 。

AIM To study the tolerance test of actarit to normal Chinese, and the test will provide the safety and effective dosage regimen for the phase Ⅱ clinical study. METHODS 26 healthy volunteers were selected for study of the tolerance test of actar it to human being, male 13, female 13. They were randomly divided into 5 groups by the stratified method. Each group had half of men and women 4, 4, 6, 6, and 6 people respectively. There were 5 dose groups, such as 100, 200, 400, 600, and 800 mg respectively, They took drug from 100 mg to 800 mg. We observed HR, R, T, BP, EKG, adverse reactions to actar it, blood RT, hepatic and renal functions before and after test. RESULTS In every test group, every volunteer did not have obvious adverse reactions to actarit. Before and after test, HR, R, T, BP, EKG, were normal respectively, and blood RT, hepatic and renal functions were not significant change. CONCLUSION 26 healthy volunteers who took actarit (100～800 mg) respectively had a good tolerance to actarit. Moreover, the phase Ⅱ clinical test can refer to the dosage ranges when the clinical dose is selected.