ACTRN12615000127505已完成1 期
A phase I, Open label, Single-center, Dose-increasing Study to Determine the Pharmacokinetics of Single and Repeated oral administration of Nebivolol Hydrochloride in Healthy Chinese Volunteers
Fuwai hospital0 个研究点目标入组 67 人开始时间: 2015年2月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
研究概览
简要总结
none
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking 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, heart rate and laboratory test results(hematology, blood biochemistry, hepatic function, and urinalysis), negative results on HIV and hepatitis types B and C testing)
- •Genotype of CYP2D6 is *1*1(wild) or *10*10(Homozygous mutant)
排除标准
- •1. weight less than 50kg, weight index less than 19 or more than 24;
- •2. low blood pressure history or blood pressur <90/60mmHg;
- •3. bradycardia, sinus arrest, sinoatrial block, atrioventricular blocker, 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, tape or foods;
- •7.use of prescription or over-the-counter medication including herbal products within 4 week 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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