EUCTR2018-001265-17-FI进行中（未招募）1 期
Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis (EdoRot).
Turku University Central Hospital0 个研究点目标入组 15 人开始时间: 2018年7月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Healthy male volunteers
- •2.Age of 18 - 40 years
- •3.Written informed consent from the participating subject
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.A previous history of intolerance to the study drug or related compounds and
- •2.History of bleeding disorder or similar
- •3.History of alcoholism, drug abuse, psychiatric, psychological or other emotional problems that are likely to invalidate informed consent
- •4.BMI = 20 or = 35
- •5.Concomitant drug therapy of any kind for at least 14 days prior to the study
- •6.Existing or recent significant disease
- •7.A yes” answer to any one of the Abuse Questions.
- •8.Donation of blood for 4 weeks prior and during the study.
- •9.Special diet or life style conditions which would compromise the conditions of the study or interpretation of the results. Drinking grapefruit juice and eating grapefruits is forbidden one week before the research and during the research itself.
- •10.Participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
- •11.Smoking for one month before the start of the study and during the whole study period.
研究者
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