中国医院用药评价与分析2017，Vol.17Issue(11)：1460-1463,4.DOI:10.14009/j.issn.1672-2124.2017.11.006
血脂泰分散片Ⅰ期临床人体耐受性研究
Phase Ⅰ Clinical Tolerable Study of Xuezhitai Dispersible Tablets on Human
摘要
Abstract
OBJECTIVE:To investigate the tolerance and safety of different dose of Xuezhitai dispersible tablets on human body , so as to provide safe dosage range of formulation of Xuezhitai dispersible tablets in phase Ⅱ clinical trials.METHODS: The opened, randomized, multi-doses, self-controlled design was adopted , single dose and continuous administration tolerance test of Xuezhitai dispersible tablets were conducted on 40 healthy volunteers .Single dose group was 28 cases, totally 5 dose groups, with administration of 4 tablets, 6 tablets, 8 tablets, 10 tablets and 12 tablets (the effective site content is 20 mg per tablet ), qd.And continuous administration group was 12 healthy volunteers, totally 2 dose groups, with administration of 10 and 12 tablets, qd, for 7 days.The observation indicators were respectively vital signs , physical and chemical inspection and adverse drug reactions .Statistical analysis was conducted by using SAS software .RESULTS: One case of diarrhea was found in the single dose group and the continuous administration group , and there were no other clinically significant changes in vital signs and laboratory tests.CONCLUIONS:The application of single dose of Xuezhitai dispersible tablets ≤12 tablets or 12 tablets ≤1 dose a day, qd, for 7 days is safe for human body .关键词
血脂泰分散片/Ⅰ期临床/耐受性Key words
Xuezhitai dispersible tablets/Phase Ⅰ clinical trial/Tolerance分类
医药卫生引用本文复制引用
周翠兰,胡思源,倪天庆,黄大森,张广明..血脂泰分散片Ⅰ期临床人体耐受性研究[J].中国医院用药评价与分析,2017,17(11):1460-1463,4.基金项目
广东省重大科技专项"治疗高脂血症药物血脂泰分散片的临床研究"(No.2012A080204008) （No.2012A080204008）
广州市重大科技专项"治疗高脂血症药物血脂泰分散片的临床研究"(No.201300000044) （No.201300000044）
