NCT02226926已完成1 期
Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- VASP-Ser239 / VASP-Ser157-phosphorylation
研究概览
简要总结
Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy females/males
- •Age range from 18 to 60
- •Volunteers will have given their written informed consent in accordance with local ethics committee and local legislation
排除标准
- •Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
- •Known history of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Drug intake with long half-life (> 24 hours), < 1 month prior to administration or during the trial
- •Volunteers received any other drugs which might influence the results of the trial, < 10 days prior to administration or during the trial
- •Participation in another study with an investigational drug, < 1 month prior to administration or during the trial
- •Smoking more than 15 cigarettes or 4 cigars or 4 pipes/day
- •Drinking more than 60 g of alcohol per day
- •Unable to refrain from excessive consumption of methylxanthine containing drinks or food
- •Drug addiction
- •Blood donation (> 400 ml), < 4 weeks prior to administration or during the trial
- •Participation in excessive physical activities, < 5 days prior to administration or during the trial
- •For female volunteers:
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception (acceptable: oral contraceptives, condoms, etc.)
- •Lactation period
研究组 & 干预措施
Aggrenox
Experimental
Dipyridamole extended release / Acetylsalicylic acid
干预措施: Aggrenox (Drug)
Persantin Retard
Active Comparator
Dipyridamole extended release
干预措施: Persantin Retard (Drug)
Acetylsalicylic acid
Active Comparator
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
VASP-Ser239 / VASP-Ser157-phosphorylation
时间窗: up to day 10
induced by sodium nitroprusside (SNP) 0.5µM or SNP 0.3µM and prostaglandin E1 (PG-E1) 0.3nM (Western Blot)
次要结局
- Change in Dipyridamole plasma levels(up to day 10)
研究者
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