NCT02170831已完成1 期
Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 50, 100, 200, and 400 mg BIBR 1048 MS Solution Administered TID for 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level
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
- 40
- 主要终点
- Change in aPTT (activated partial thromboplastin time)
研究概览
简要总结
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Healthy male subjects as determined by results of screening
- •Signed written informed consent in accordance with GCP and local legislation
- •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, immunologic, hormonal disorders
- •History of orthostatic hypotension, fainting spells and 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 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 trial
- •Participation in another trial with an investigational drug within 2 months prior to administration or during 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
BIBR 1048 MS low dose
Experimental
干预措施: BIBR 1048 MS low (Drug)
BIBR 1048 MS medium dose 1
Experimental
干预措施: BIBR 1048 MS medium 1 (Drug)
BIBR 1048 MS medium dose 2
Experimental
干预措施: BIBR 1048 MS medium 2 (Drug)
BIBR 1048 MS high dose
Experimental
干预措施: BIBR 1048 MS high (Drug)
BIBR 1048 Placebo
Placebo Comparator
干预措施: BIBR 1048 MS placebo (Drug)
结局指标
主要结局
Change in aPTT (activated partial thromboplastin time)
时间窗: up to day 10
Change in PT (prothrombin time)
时间窗: up to day 10
次要结局
- tmax,ss (time to reach Cmax) of BIBR 953 ZW(up to day 10)
- Cmax (maximum measured concentration) of BIBR 953 ZW(up to day 10)
- Cavg (average plasma concentration at steady state) of BIBR 953 ZW(up to day 10)
- tmax (time from dosing to the maximum concentration) of BIBR 953 ZW(up to day 10)
- AUC0-∞ (area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW(up to day 10)
- Cmin,ss (minimum measured concentration at steady state) of BIBR 953 ZW(Day 7)
- t1/2 (terminal half-life) of BIBR 953 ZW(up to day 10)
- Cmax,ss (maximum measured concentration at steady state) of BIBR 953 ZW(Day 7)
- PTF (percent peak trough fluctuation for the last dosing interval) of BIBR 953 ZW(up to day 10)
- AUCss (area under the plasma concentration-time curve of one dosing interval at steady state) of BIBR 953 ZW(up to day 10)
- CLtot/F (total apparent clearance) of BIBR 953 ZW(up to day 10)
- MRTss (mean residence time at steady state) of BIBR 953 ZW(up to day 10)
- Vz/F (apparent volume of distribution) of BIBR 953 ZW(up to day 10)
研究者
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