血脂泰分散片Ⅰ期临床人体耐受性研究.docVIP

血脂泰分散片Ⅰ期临床人体耐受性研究 周翠兰 胡思源 倪天庆 黄大森 张广明 广州一品红制药有限公司研发中心 天津中医药大学第一附属医院儿科 X 关注成功！ 加关注后您将方便地在 我的关注中得到本文献的被引频次变化的通知！ 新浪微博 腾讯微博 人人网 开心网 豆瓣网 网易微博 摘????要： 目的:考察健康人对不同剂量血脂泰分散片的耐受性和安全性, 为制定血脂泰分散片Ⅱ期临床试验给药方案提供安全的剂量范围。方法:将筛选合格的40例健康受试者, 采用开放、随机、多剂量组及自身前后对照设计, 按顺序进行血脂泰分散片单次给药和连续给药耐受性试验。单次给药组受试者共28例, 分为5个剂量组, 给药剂量分别为4、6、8、10及12片 (有效部位含量为20 mg/片) , 1日给药1次;多次给药组受试者共12例, 分为2个剂量组, 给药剂量分别为10、12片, 1日给药1次, 连续7 d。观察指标为生命体征、理化检查、不良反应。应用SAS软件进行统计分析。结果:单次给药组和多次给药组均有1例受试者发生腹泻不良反应, 其他生命体征及实验室检查未见与药物有关的具有临床意义的变化。结论:血脂泰分散片单次给药≤12片;或剂量≤1次12片, 1日1次, 连续给药7 d, 在人体的应用是安全的。 关键词： 血脂泰分散片; Ⅰ期临床; 耐受性; 作者简介：周翠兰 工程师。研究方向:新药开发。E-mail:t001@ 作者简介：张广明 高级工程师。研究方向:新药开发。E-mail:gmzhang2005@163.com 收稿日期：2017-07-14 基金：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) Phase Ⅰ Clinical Tolerable Study of Xuezhitai Dispersible Tablets on Human ZHOU Cuilan HU Siyuan NI Tianqing HUANG Dasen ZHANG Guangming Research and Development Center, Guangzhou Yinpinhong Pharmaceutical Co., LTD; Dept. of Pediatrics, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine; 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 condu