单次口服甲磺酸加替沙星片安全性、耐受性研究.pdfVIP

单次口服甲磺酸加替沙星片安全性 耐受性研究 周筱青 柴栋 王睿 方翼 裴斐 朱曼 解放军总医院药材处 北京 100853 摘要 目的 在中国健康成年志愿者中评估单次口服甲磺酸加替沙星的安全 性 耐受性 方法 根据新药临床试验指导原则设计试验方案 并获得解放军总 医院伦理委员会审查通过 选择 18 50 岁健康成人 用区组随机化设计方法 将36 名受试者随机分配至100mg 200mg 300mg 400mg 500mg 600mg 组 每组6 名受试者 男女各半 观察试验期间发生的不良事件 以及临床症状 体 征 实验室指标变化 结果 各组入选受试者各项指标测定值均在正常范围 条 件均衡 具较好可比性 试验中未见严重的临床不良反应 仅 600mg 组给药后 出现一例头晕 头痛 可能与药物有关 结论 中国健康受试者单次口服甲磺酸 加替沙星片 最大剂量至600mg 比较安全 耐受性较好 关键词 甲磺酸加替沙星 耐受性 中国志愿者 The Tolerance of Single –Dose of Gatifloxacin Mehanesulfanae tablet in Chinese Health Volunteers ZHOU Xiao-Qing , CHAI Dong, WANG Rui, FANG Yi, PEI Fei, ZHU Man (Department of pharmacy, Chinese PLA General Hospital Beijing 100853 ) Abstract OBJECTIVE To evaluate the safety and tolerance of single-dose of gatifloxacin mehanesulfanae tablet in Chinese healthy volunteers treated. METHODS The clinical trial protocol was designed according to the Good Clinical Practice(GCP) and passed by the ethics committee. After physical examination and laboratory tests were performed, 36 healthy volunteers in 18 50 years old were divided into100mg 200mg 300mg 400mg 500mg 600mg groups respectively Clinical symptoms, vital signs and laboratory tests were observed or examined before and after administration. RESULTS The vital signs, clinical symptoms and laboratory tests of every group were mainly in the normal range. There are no serious ADRs during the trial, in addition that 1 case of headache and dizzy was found in 600mg group, which maybe associated with the drug. CONCLUSION It was safe and tolerable that Chinese healthy volunteers were treated by single-dose of gatifloxacin mehanesulfanae tablet, until the dosage is up to 600mg. Key Words Gatifloxacin mehanesulfanae;