NCT02170740已完成1 期
Bioavailability of BIBR 953 ZW After Multiple Oral Doses of 50 and 200 mg BIBR 1048 MS Film-coated Tablet Administered BIDfor 3 Days or 200 mg BIBR 1048 MS With and Without Pre-treatment With Pantoprazole to Healthy Volunteer Subjects. Two Groups, 2-way Crossover, Randomised, 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
- 26
- 主要终点
- Urinary excretion of total BIBR 953 ZW
研究概览
简要总结
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 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 ≤ 50 years
- •Broca ≥ - 20% and ≤ + 20%
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (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
- •History of any bleeding disorder including prolonged or habitual bleeding
- •History of other hematologic disease
- •History of cerebral bleeding (e.g. after a car accident)
- •History of commotio cerebri
- •Intake of drugs with a long-life (> 24 hours) within 1 month prior to administration
- •Use of any drug which might influence the results of the trial within 10 days prior to administration or during the trial
- •Participation in another trial with 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 (> 60g/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 familiar bleeding disorder
- •Thrombocytes < 150000/µl
研究组 & 干预措施
BIBR 1048 MS
Experimental
干预措施: BIBR 1048 MS - low dose (Drug)
BIBR 1048 MS
Experimental
干预措施: BIBR 1048 MS - high dose (Drug)
BIBR 1048 MS + Pantoprazole
Experimental
干预措施: BIBR 1048 MS - high dose (Drug)
BIBR 1048 MS + Pantoprazole
Experimental
干预措施: BIBR 1048 MS + Pantoprazole (Drug)
结局指标
主要结局
Urinary excretion of total BIBR 953 ZW
时间窗: Day 1, day 2, day 3 (different time points)
Amount of total (free and glucuronide) BIBR 953 ZW excreted in urine over one dosing interval
时间窗: Day 1, day 2, day 3 (different time points)
Peak (maximum) plasma concentration at steady state (Cmax,ss) of BIBR 953 ZW
时间窗: Day 1, day 2, day 3 (different time points)
Area under the plasma concentration-time curve at steady state (AUCss) of BIBR 953 ZW
时间窗: Day 1, day 2, day 3 (different time points)
次要结局
- Time to reach the peak plasma concentration (Tmax,ss) of BIBR 953ZW(Day 1, day 2, day 3 (different time points))
- Occurence of adverse events(6 weeks)
- Change from Baseline in pulse rate(Baseline, day 1,day 2, day 3, day 4)
- Change from Baseline in systolic and diastolic blood pressure(Baseline, day 1,day 2, day 3, day 4)
- Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration(Day 1, day 2, day 3 (different time points))
- Change from Baseline in clinical laboratory tests(Baseline, day 1,day 2, day 3, day 4)
- Changes from baseline in activated partial thromboplastin time (aPTT)(Day 1, day 2, day 3 (different time points))
- Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR))(Day 1, day 2, day 3 (different time points))
- Total mean residence time (MRTtot) of BIBR 953 ZW after oral administration(ay 1, day 2, day 3 (different time points))
研究者
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