NCT00856817终止4 期
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Adenosine induced vasodilation
研究概览
简要总结
The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate treatment is of influence on adenosine induced vasodilation in healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 18 and no older than 65 on the day of first dosing
- •Quetelet Index (Body Mass Index) of 18 to 30 kg/m2
- •In general, results of haematology and chemistry should be within the laboratory's reference ranges. Determinants of renal and hepatic function should be within twice the upper limit of normal range.
排除标准
- •Documented history of sensitivity / idiosyncrasy to medicinal products or excipients
- •history of smoking within the past year
- •history of or current abuse of drugs, alcohol and/or solvents
- •Current use of any (over the counter) medication potentially influencing heme oxygenase or the cardiovascular system
- •Inability to understand the nature and extent of the trial and the procedures required
- •Participation to a drug trial within 60 days prior to the first dose
- •Febrile illness within 3 days before the first dose
- •Heterozygosity (LS) or homozygosity (LL) with regard to the number of GT repeats in the HO-1 promoter region
研究组 & 干预措施
1
Experimental
L-arginine treatment first, heme arginate treatment second
干预措施: L-arginine + heme arginate (Drug)
2
Experimental
Heme arginate treatment first, L-arginine treatment second
干预措施: Heme arginate + L-arginine (Drug)
结局指标
主要结局
Adenosine induced vasodilation
时间窗: following a three day treatment with either heme arginate or L arginine
次要结局
- heme oxygenase expression and activity(assessed during and following a three day treatment with either heme arginate or L-arginine)
研究者
研究点 (1)
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