NCT02222987已完成1 期
Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Oral Doses of 100 mg Terbogrel Bid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Change in inhibition of platelet aggregation in platelet rich plasma (PRP)
研究概览
简要总结
Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100 mg terbogrel bid.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- •Healthy male subjects
- •Age >= 18 and <= 45 years
- •Broca >= -20% and <= +20 %
排除标准
- •Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- •Chronic or relevant acute infections
- •History of
- •allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •any bleeding disorder including prolonged or habitual bleeding
- •other hematologic disease
- •cerebral bleeding (e.g. after car accident)
- •commotio cerebri
- •Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- •Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within 2 months days prior to administration or during the trial
- •Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- •Alcohol (> 60 g/day) abuse
- •Drug abuse
- •Blood donation within 1 month prior to administration or during the trial
- •Excessive physical activities within 5 days prior to administration or during the trial
- •Any laboratory value outside the reference range of clinical relevance
- •History of any familial bleeding disorder
- •Thrombocytes < 150000/µl
研究组 & 干预措施
Terbogrel
Active Comparator
干预措施: Terbogrel (Drug)
Terbogrel with Clopidogrel
Experimental
干预措施: Terbogrel (Drug)
Terbogrel with Clopidogrel
Experimental
干预措施: Clopidogrel (Drug)
Clopidogrel
Active Comparator
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Change in inhibition of platelet aggregation in platelet rich plasma (PRP)
时间窗: baseline, up to day 17
Change in thromboxane receptor occupancy (TRO)
时间窗: baseline, up to day 17
Change in 6-keto-prostaglandinF-1-alpha
时间窗: baseline, up to day 17
Change in thromboxan synthesis inhibition (TSI)
时间窗: baseline, up to day 17
次要结局
- Change in bleeding time(baseline, up to day 17)
- Change in systolic and diastolic blood pressure(baseline, up to day 17)
- Change in pulse rate(baseline, up to day 17)
- Plasma levels of terbogrel(up to day 17)
- Number of patients with adverse events(up to day 17)
- Number of patients with haematuria(up to day 17)
- Number of patients with positive Haemoccult test(up to day 17)
- Number of patients with clinically significant laboratory findings(up to day 17)
研究者
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