NCT01226602已完成1 期
A Randomized, Double-blind, Placebo Controlled, Crossover, Single Centre Phase I Study to Assess the Effect of Ticagrelor on Adenosine-induced Coronary Blood Flow Velocity in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug.
研究概览
简要总结
The purpose of this study is to determine if Ticagrelor increases the Adenosin induced coronary blood flow velocity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Suitable for ECG recording of CBFV and have no adverse reaction to adenosine challenge
- •Have a body mass index between 18 and 30 kg/m2
排除标准
- •History of clinically significant disease or disorder.
- •Abnormal vital signs
研究组 & 干预措施
1
Experimental
Adenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder
干预措施: AZD6140 (Drug)
2
Placebo Comparator
Adenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder
干预措施: Placebo (Drug)
结局指标
主要结局
Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug.
时间窗: During 6 h at visit 3
次要结局
- Effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity by estimating the change in area under the adenosine dose response curve before and after infusion of theophylline.(During 6 h at visit 2)
- Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline.(During 6 h at visit 3)
研究者
研究点 (1)
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