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

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、25mg剂量组，其中2．5、25mg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25mg，比较安全，耐受性较好。

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

AIM: To evaluate the safety and toler-ability 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.