NCT02170792已完成1 期
Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three 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
- 30
- 主要终点
- Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h)
研究概览
简要总结
To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.
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 <0 + 20%
排除标准
- •any finding of the medical examination (including blood pressure, pulse rate and ECG)
- •history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- •history of orthostatic hypotension, fainting spells and blackouts
- •diseases of 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 administration
- •participation in another trial with an investigational drug within 2 month 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 with ranitidine
Experimental
Low, medium or high dose in combination with ranitidine
干预措施: BIBR 1048 MS (Drug)
BIBR 1048 MS with ranitidine
Experimental
Low, medium or high dose in combination with ranitidine
干预措施: Ranitidine (Drug)
BIBR 1048 MS without ranitidine
Experimental
Low, medium or high dose
干预措施: BIBR 1048 MS (Drug)
结局指标
主要结局
Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h)
时间窗: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Area under the plasma drug concentration time curve of BIBR 953 ZW within the interval from zero time to tf (last quantifiable plasma concentration) (AUC0-tf)
时间窗: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
次要结局
- Time from dosing to the maximum concentration of the analyte in plasma (tmax)(before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment)
- Changes from baseline in blood pressure (systolic and diastolic)(baseline up to 36 h after last administration)
- Maximum concentration of drug in plasma ( Cmax )(before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment)
- Number of participants with adverse events(up to 36 h after last administration)
- Changes in activated prothrombin time (aPTT)(before and 2 hours after treatment)
- Changes from baseline in Pulse rate(baseline up to 36 h after last administration)
- Changes from baseline in ECG(baseline up to 36 h after last administration)
- Changes from baseline in routine laboratory(baseline up to 36 h after last administration)
- Changes in international normalized ratio (INR )(before and 2 hours after treatment)
研究者
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