NCT00853450已完成1 期
A Randomised, Open-label, Single-Centre, Phase I, Crossover Study to Evaluate the Effect of AZD6482, Compared With Clopidogrel, on Bleeding Time in Healthy Volunteers Receiving Low-Dose ASA
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
- 28
- 试验地点
- 1
- 主要终点
- Capillary Bleeding Time (CBT)
研究概览
简要总结
The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
- •Provision of written informed consent
排除标准
- •Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
- •Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse
- •Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome
研究组 & 干预措施
2
Active Comparator
Clopidogrel on top of ASA
干预措施: Clopidogrel (Drug)
1
Experimental
AZD6482 on top of ASA
干预措施: ASA (Drug)
2
Active Comparator
Clopidogrel on top of ASA
干预措施: ASA (Drug)
1
Experimental
AZD6482 on top of ASA
干预措施: AZD6482 (Drug)
结局指标
主要结局
Capillary Bleeding Time (CBT)
时间窗: Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B
次要结局
- Effect on bleeding(Prior to first dose in each treatment period, twice on study day 6 and three times on study day 7 in treatment period A and twice on study day 7 in treatment period B)
- Pharmacokinetics(Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion)
- Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)(Repeatedly during the study)
研究者
研究点 (1)
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