ACTRN12616000034437暂停1 期
A Phase I Single-Center Study to Determine the Pharmacokinetics and Pharmacodynamics of Nifekalant in Healthy Chinese Male Volunteers.
Fuwai hospital0 个研究点目标入组 36 人开始时间: 2016年1月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 19 Years 至 40 Years（—）
- 性别
- Male
入选标准
- •Healthy male Chinese volunteers between the ages of 19-40. 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, vital signs abnormal(SBP < 90mmHg or > 140mmHg, DBP < 50mmHg or > 90mmHg, HR < 50 bpm or > bpm).
- •2, Electrocardiographic abnormality with clinical significance or QTc interval > 400ms.
- •3, Holter monitor found sinus beat stop, third degree sinoatrial conduction block, atrioventricular block or heterotopic heart rate.
- •4, clinical significant allergies to drug or foods;
- •5, alcohol or drug abuse;
- •6, alcoholics or frequent drinkers 6 months before the study (that is 14 unit of alcohol weekly).
- •7, heavy smoker or smoking amount more than 5 cigarettes 3 months before the study
- •8, positive results on HIV and hepatitis types B and C testing
- •9, donate blood or participated in other clinical trials within 3 months before enrollment in the study.
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