【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。更多还原

【Abstract】 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 hydrochloride range from 2.5 mg to 25 mg in healthy Chinese volunteers were safe and tolerable in 52 healthy Chinese volunteers.更多还原