异丁司特胶囊正常人体耐受性研究  

Tolerability of the Ibudilast Capsule in Healthy Volunteers

作　　者：张京玲[1] 焦建杰[1] 肖向茜[1] 娄建石[1] 张才丽[1] 

机构地区：[1]天津医科大学临床药理研究室,天津300070

出　　处：《中国临床药理学杂志》2002年第5期345-348,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的:观察中国健康男、女性志愿者对异丁司特胶囊的耐受性。方法:32名青年男、女入选受试者参加了单剂量耐受性试验;8名男性受试者入选参加每次10mg,q12h,持续8d的连续给药耐受性试验。分别比较单次给药和连续给药试验中给药前与给药后受试者的临床症状和实验室化验结果的变化。结果:在单次口服2.5,5,10,20和30mg异丁司特胶囊时,服药后1,3,6,12,24,48h时受试者的体征和实验室检查结果与给药前比较没有区别。连续给药耐受性试验结果显示服药后第5d和第10d受试者的体征和实验室检查结果与给药前比较也没有区别。结论:受试者对异丁司特胶囊具有很好的耐受性,推荐临床一次10mg的应用剂量是可以接受的。OBJECTIVE: To observe the tolerability of ibudilast capsule in Chinese healthy male and female volunteers. METHODS: Thirty-two volunteers were enrolled in single-dose ascending dose trial; eight volunteers were enrolled in multiple-dose trial. Comparisons were made on the clinical symptoms and lab examinations acquired pre dosing and after dosing in the single-dose and multiple-dose regimens respectively. RESULTS: Single dose 2.5mg, 5mg, 10mg, 20mg or 30mg of ibudilast capsule oral administration not affect the vital signs of the subjects. There was no abnormal value in the lab examinations pre dosing and 1hr, 3hr, 6hr, 12hr, 24hr and 48hr after dosing. When subject took 10mg of ibudilast capsule, Q12h, for 8 days, no significant change was found in the clinical symptoms and lab examinations. CONCLUSIONS: The results suggest that the tolerability of ibudilast capsule is good, and 10mg of ibudilast capsule as once a time dosage time recommended for clinical use is acceptable.

关 键 词：异丁司特胶囊 单次给药耐受性 连续给药耐受性 耐受性试验 平喘药 

分 类 号：R974.3[医药卫生—药品]