NCT02265289已完成1 期
Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Fradafiban After Oral Doses of 30 mg Lefradafiban Tid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial.
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
- 14
- 主要终点
- Area under the concentration-time curve of the analyte in plasma (AUC)
研究概览
简要总结
To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg Lefradafiban tid
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 finding 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, hormonal disorders
- •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 a 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 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 abuse (> 60 g/day)
- •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 clinically accepted reference range
- •History of any familial bleeding disorder
- •Thrombocytes < 150000/µl
研究组 & 干预措施
Lefradafiban with clopidogrel
Experimental
All patients received the same treatment:
- Lefradafiban only (day 1-4)
- Lefradafiban in combination with Clopidogrel (day 5-8)
- Clopidogrel only (day 9-12)
干预措施: Lefradafiban (Drug)
Lefradafiban with clopidogrel
Experimental
All patients received the same treatment:
- Lefradafiban only (day 1-4)
- Lefradafiban in combination with Clopidogrel (day 5-8)
- Clopidogrel only (day 9-12)
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma (AUC)
时间窗: Up to 383:30 hours after first drug administration
Inhibition of platelet aggregation in platelet rich plasma (PRP)
时间窗: Up to 383:30 hours after first drug administration
Maximum concentration of the analyte in plasma at steady state (Cmax)
时间窗: Up to 383:30 hours after first drug administration
Amount of the analyte excreted unchanged in the urine (Ae)
时间窗: Up to 176:00 hours after first drug administration
Fibrinogen receptor occupancy levels (FRO)
时间窗: Up to 383:30 hours after first drug administration
次要结局
- Number of subjects with adverse events(up to 5 days after last drug administration)
- Changes from baseline in bleeding time(Pre-dose and 384:30 hours after first drug administration)
- Changes from baseline in 12-lead ECG(Pre-dose and 384:30 hours after first drug administration)
- Number of subjects with clinically significant findings in vital signs(up to 5 days after last drug administration)
研究者
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