左奥硝唑片Ⅰ期临床耐受性试验

中国临床药理学与治疗学 ›› 2011, Vol. 16 ›› Issue (4): 412-416.

左奥硝唑片Ⅰ期临床耐受性试验

谢安云¹, 程泽能², 欧阳冬生³, 郭歆², 黄志军⁴, 张桂香⁵, 刘畅⁴, 谭鸿毅⁴, 阳丽⁴, 阳国平⁴

¹湖南医药工业研究所, ²中南大学药学院, ³中南大学临床药理研究所, ⁴中南大学湘雅三医院, ⁵湖南省第二人民医院,长沙 410014,湖南

收稿日期:2010-08-31 修回日期:2010-11-20 发布日期:2011-06-22
通讯作者: 阳国平,男,副教授,硕士生导师,研究方向:临床药理学和药动学。Tel: 0731-88618339 E-mail:ygp9880@163.com
作者简介:谢安云,女, 副研究员,研究方向:新药开发与临床研究。

Phase Ⅰ clinical tolerability trial of (S)-ornidazole tablets

XIE An-yun¹, CHENG Ze-neng², OU-YANG Dong-sheng³, GUO Xin², HUANG Zhi-jun⁴, ZHANG Gui-xiang⁵, LIU Chang⁴,TAN Hong-yi⁴,YANG Li⁴, YANG Guo-ping⁴

¹Hunan Institute of Pharmaceutical Industry, ²School of Pharmaceutical Sciences of Central South University, ³Institute of Clinical Pharmacology of Central South University, ⁴Xiangya 3rd Hospital of Central South University, ⁵Second People's Hospital of Hunan Province, Changsha 410014, Hunan,China

Received:2010-08-31 Revised:2010-11-20 Published:2011-06-22

摘要/Abstract

摘要： 目的: 评价健康人体对左奥硝唑片的耐受性。 方法: 采用随机、盲法、安慰剂对照的单中心临床研究。48名健康受试者经筛选进入临床试验,其中38名健康受试者随机分为4组参加了单次给药耐受性试验,各组剂量分别为250、500、1000、1500 mg。10名健康受试者参与了为期 7 d 的连续给药耐受性试验,剂量为 1000 mg。各组均设2例安慰剂。观察受试者用药前后生命体征、心电图及实验室检查的变化,并观察和记录不良事件。 结果: 在单次和多次给药耐受性试验中,受试者用药前后生命体征、心电图及实验室检查均没有临床意义的改变。20名受试者发生轻度不良事件,表现为头晕、乏力、困倦、恶心等。 结论: 健康受试者服用左奥硝唑片日剂量250～1000 mg,可安全耐受。

关键词: 左奥硝唑片, 单次给药, 多次给药, 耐受性试验

Abstract: AIM: To evaluate the tolerability of (S)-ornidazole in healthy volunteers. METHODS: It is a randomized, blinded, placebo-controlled single-center clinical study. Fowrty-eight healthy volunteers enrolled the study. Thirty-eight healthy volunteers were randomly divided into four groups to attend single-dose tolerability trial (250, 500, 1000, 1500 mg, respectively). Ten healthy volunteers entered multi-dose tolerability trial for 7 days [1000 mg (S)-ornidazole, Qd]. Two healthy volunteers of each group were given placebo.Vital signs, electrocardiogram and serum biochemical indicators were observed before and after (S)-ornidazole administration and adverse effects were recorded. RESULTS: In the study, there were no abnormal findings in vital signs, electrocardiogram and serum biochemical indicators.20 healthy volunteers experienced mild adverse effects of dizziness, fatigue, drowsiness nausea and so on. CONCLUSION: (S)-ornidazole tablet is safe for healthy volunteers at daily dose of 250 to 1000 mg

Key words: (S)-ornidazole, Single-dose, Multi-dose, Tolerability trial

中图分类号:

R969.4

谢安云, 程泽能, 欧阳冬生, 郭歆, 黄志军, 张桂香, 刘畅, 谭鸿毅, 阳丽, 阳国平. 左奥硝唑片Ⅰ期临床耐受性试验[J]. 中国临床药理学与治疗学, 2011, 16(4): 412-416.

XIE An-yun, CHENG Ze-neng, OU-YANG Dong-sheng, GUO Xin, HUANG Zhi-jun, ZHANG Gui-xiang, LIU Chang,TAN Hong-yi,YANG Li, YANG Guo-ping. Phase Ⅰ clinical tolerability trial of (S)-ornidazole tablets[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2011, 16(4): 412-416.

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