中国健康成年志愿者单次口服盐酸埃他卡林片耐受性研究  

Tolerability research of single dose of iptakalim hydrochloride in healthy Chinese volunteers

作　　者：方翼[1,2] 王睿[3] 柴栋[3] 崔文玉[4] 汪海[4] 管华诗[1] 

机构地区：[1]中国海洋大学海洋药物与食品研究所 [2]北京大学人民医院药剂科,北京100044 [3]中国人民解放军总医院临床药理室,北京100853 [4]军事医学科学院毒物药物研究所,北京100850

出　　处：《中国临床药理学与治疗学》2009年第5期546-550,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的:在中国健康成年志愿者体内评估单次口服盐酸埃他卡林片的安全性、耐受性。方法:采用区组随机化设计,选择18～50岁健康志愿者52名,随机分配至2.5、5、10、15、20、25 mg剂量组,其中2.5、25 mg组各有6名受试者,其余各组均有10名受试者,男女各半,每组中均有2人(男、女各1人)接受安慰剂。严密观察给药前后的临床症状、体征、实验室指标变化,并观察试验期间发生的不良事件。结果:入选受试者给药后症状、体征以及实验室检查指标均未见有异常的改变。试验中未见严重不良事件,未见可能与药物有关的临床不良反应。结论:52名中国健康受试者单次空腹口服盐酸埃他卡林片最大剂量达25 mg,比较安全,耐受性较好。AIM： To evaluate the safety and tolerability of single dose of iptakalim hydrochloride in healthy Chinese volunteers. METHODS： 52 healthy volunteers in 18 - 50 years old were chosen and randomized into 6 dose groups, including 2.5,5,10, 15, 20,25 mg. Group B, C, D, E contained 10 volunteers respectively, and Group A and F contained 6 volunteers. Each group contained 2 volunteers （ 1 male and 1 female） who were administrated with placebo. Clinical symptoms, vital signs, the changes of laboratory examination indexes, and all adverse drug events were observed. RESULTS： After single dose of 2.5 - 25 mg,the clinical symptoms, vital signs and index of laboratory examination were in normal range. There were no severe adverse events, and no adverse events were related to the drug. CONCLUSION： The single-dose of iptakalim hydroehloride range from 2.5 mg to 25 nag in healthy Chinese volunteers were safe and tolerable in 52 healthy Chinese volunteers.

关 键 词：盐酸埃他卡林 安全性 耐受性 

分 类 号：R544.1[医药卫生—心血管疾病]