ACTRN12613000277741已完成1 期
A Phase 1, Open Label, Single-Center, Dose-increasing Study to Determine the Safety and Pharmacokinetics of Single and Repeated oral administration of ivabradine in Healthy Chinese Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •Body mass index between 19 and 24 kg/m^2, nonsmokers, thorax radiography and electrocardiography without abnormalities, normal values of BP and heart rate and laboratory test results(hematology, blood biochemistry, hepatic function, and urinalysis), negative results on HIV and hepatitis types B and C testing.
排除标准
- •1. weight less than 50kg , weight index less than 19 or weight index more than 24
- •2.low blood pressure
- •3.bradycardia,sinus arrest, sinoatrial block, atrioventricular block, ectopic rhythm Holter monitoring ;
- •4.disease or disorders in hepatic, renal, respiratory, immune system and nervous system;
- •5.alcohol or drug abuse;
- •6.clinical significant allergies to drug or foods;
- •7.use of prescription or over-the-counter medication including herbal products within 4 weeks before study initiation;
- •8.donate blood or participated in other clinical trials within 3 months before enrollment in the study
- •9.positive results on HIV and hepatitis types B and C testing
- •10.abnormalities in laboratory test(hematology, blood biochemistry, hepatic function, and urinalysis)
研究者
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