NCT02170896已完成1 期
Bioavailability of BIBR 953 ZW After 50 mg of BIBR 1048 MS (Oral Prodrug of BIBR 953) in 4 Experimental Formulations Relative to Drinking Solution of BIBR 1048 MS, Each Treatment Given Bid Over 3 Days, in Healthy Subjects. Intraindividual Comparison (5-way Crossover), Randomised, Open. For Each of the 5 Treatments, Investigation of 2 Conditions: With and Without Pantoprazole (Intraindividual, Open Comparison).
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
- 16
- 主要终点
- Ae 0-12h: amount of drug (total BIBR 953 ZW) excreted into urine during all individual dosing intervals
研究概览
简要总结
To assess the amount of BIBR 953 ZW in urine of 50 mg of BIBR 1048 bid over three days each administered as four experimental capsule formulations relative to drinking solution with and without coadministration of 40 mg pantoprazole.
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 55 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 (Good Clinical Practice) and local legislation
- •Age >= 18 and <= 55 years
- •Body Mass Index (BMI) >= 18.5 and <= 29.9 kg/m²
排除标准
- •Any finding at the medical examination (including blood pressure, pulse rate and ECG (electrocardiogram)) deviation from normal and of clinical relevance
- •History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- •History of relevant 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 drug with a long half-life (> 24 hours) within 1 month prior to administration
- •Use of any drugs that 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 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 familial bleeding disorder
- •Thrombocytes < 150000/µl
研究组 & 干预措施
Period 2: BIBR1048 MS solution
Active Comparator
干预措施: BIBR 1048 MS tartaric acid solution (Drug)
Period 1: BIBR1048 MS Capsule C+Pantoprazole
Experimental
干预措施: Pantoprazole (Drug)
Period 1: BIBR1048 MS Capsule D+Pantoprazole
Experimental
干预措施: BIBR 1048 MS Capsule D (Drug)
Period 1: BIBR1048 MS Capsule D+Pantoprazole
Experimental
干预措施: Pantoprazole (Drug)
Period 1: BIBR1048 MS solution+Pantoprazole
Active Comparator
干预措施: BIBR 1048 MS tartaric acid solution (Drug)
Period 1: BIBR1048 MS solution+Pantoprazole
Active Comparator
干预措施: Pantoprazole (Drug)
Period 2: BIBR1048 MS Capsule C
Experimental
干预措施: BIBR 1048 MS Capsule C (Drug)
Period 2: BIBR1048 MS Capsule D
Experimental
干预措施: BIBR 1048 MS Capsule D (Drug)
Period 1: BIBR1048 MS Capsule B+Pantoprazole
Experimental
干预措施: Pantoprazole (Drug)
Period 1: BIBR1048 MS Capsule C+Pantoprazole
Experimental
干预措施: BIBR 1048 MS Capsule C (Drug)
Period 1: BIBR1048 MS Capsule A+Pantoprazole
Experimental
干预措施: BIBR 1048 MS Capsule A (Drug)
Period 1: BIBR1048 MS Capsule A+Pantoprazole
Experimental
干预措施: Pantoprazole (Drug)
Period 1: BIBR1048 MS Capsule B+Pantoprazole
Experimental
干预措施: BIBR 1048 MS Capsule B (Drug)
结局指标
主要结局
Ae 0-12h: amount of drug (total BIBR 953 ZW) excreted into urine during all individual dosing intervals
时间窗: up to 3 days after each administration
Area under the concentration time course at steady state (AUCss)
时间窗: 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2
次要结局
- Occurence of adverse events(up to 40 days)
- Maximum plasma concentration at steady state (Cmax,ss)(0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2)
- Time at which maximum plasma concentration occurs after dosing during steady state (tmax,ss)(0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2)
研究者
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