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 胡思源 倪天庆 黄大森 张广明 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 摘要： 口的: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 do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 牛腹泻不良反应，其他牛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W12片;或剂量W1次12片，1日1次，连 续给药7d,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: t00 l@gdyph. com 作者简介：张广明高级工程师。研究方向:新药开发。 E-mai1: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 Cu订an HUSivuan 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-control1ed dcsign was adoptcd， single dose and continuous administration tolcrancc 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 continu ous adm inistreition group was 12 hca lthy voluntc crs，tot ally 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 con due ted by using SAS software. RESULTS: One case of diarrhea was fou