NCT02170974已完成1 期
Bioavailability of BIBR 953 ZW After 150 mg of BIBR 1048 (Oral Pro-drug of BIBR 953 ZW) Administered as HPMC Polymorph II Capsule Relative to 150 mg HPMC Polymorph I Capsule in Healthy Subjects. A Two-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
- 28
- 主要终点
- AUC0-infinity (area under the plasma concentration-time curve of BIBR 953 ZW from 0 to infinity)
研究概览
简要总结
Investigation of the relative bioavailability of BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph II versus BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph I in HPMC capsules
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male subjects as determined by results of screening
- •Signed written informed consent in accordance with GCP and local legislation
- •Age ≥ 18 and ≤ 55 years
- •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) deviating 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
- •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 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 (> 60 g/day)
- •Drug abuse
- •Blood donation of more than 400 ml within 4 weeks 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 reference range of clinical relevance
- •History of any familial bleeding disorder
- •Platelets < 150000/μl
研究组 & 干预措施
BIBR 1048 MS polymorph II
Experimental
干预措施: BIBR 1048 MS polymorph II (Drug)
BIBR 1048 MS polymorph I
Active Comparator
干预措施: BIBR 1048 MS polymorph I (Drug)
结局指标
主要结局
AUC0-infinity (area under the plasma concentration-time curve of BIBR 953 ZW from 0 to infinity)
时间窗: 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration
AUC0-tz
时间窗: 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration
Cmax (maximum measured plasma concentration of BIBR 953 ZW)
时间窗: 0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration
次要结局
- tmax (time from dosing to when the plasma concentration reaches Cmax after extravascular doses )(0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration)
- t1/2 (half life)(0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration)
- MRTpo (mean time of residence of drug molecules in the body)(0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration)
- CL/F (apparent clearance after oral administration)(0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration)
- Vz/F (apparent volume of distribution)(0 h (predose), 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 24 h, 48 h, and 72 h after drug administration)
- Changes in ECG(up to 31 days)
- Changes in systolic and diastolic blood pressure(up to 31 days)
- Occurrence of adverse events(up to 31 days)
- Assessment of tolerability by investigator on a four-point scale(up to 31 days)
研究者
相似试验
已完成
1 期
Bioavailability of BIBR 953 ZW Under Influence of Food in Healthy SubjectsHealthyNCT02170597Boehringer Ingelheim12
已完成
1 期
Bioavailability of BIBR 1048 MS With and Without Pantoprazole Under Influence of Food in Healthy SubjectsHealthyNCT02170610Boehringer Ingelheim18
已完成
1 期
Bioavailability of BIBR 953 ZW After Oral Administration of BIBR 1048 MS in Healthy SubjectsHealthyNCT02170636Boehringer Ingelheim15
已完成
1 期
Bioavailability of BIBR 953 ZW After Administration of BIBR 1048 MS in Healthy SubjectsHealthyNCT02170623Boehringer Ingelheim12
已完成
1 期
Bioavailability of BIBR 953 ZW in Healthy SubjectsHealthyNCT02170766Boehringer Ingelheim48