NCT02273427已完成1 期
Randomised 3-way Cross-over Phase I Study to Investigate the Effect of Different Food Compositions (Low Fat and High Fat Meal) on Bioavailability of BIIL 284 BS 75 mg Tablet in Healthy Male Volunteers
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
- 24
- 主要终点
- Maximum concentration (Cmax)
研究概览
简要总结
food effect, relative bioavailability, pharmacokinetics, safety and tolerability
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
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All participants in the study should be healthy caucasian males as determined by the results of screening, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index)
- •All volunteers will have given their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
- •Use of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial)
- •Participation in another trial with an investigational drug (<= two months prior to administration or during the trial)
- •Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (>= 100 ml within four weeks prior to administration or during the trial)
- •Excessive physical activities (within the last week before the study)
- •Any laboratory value outside the reference range of clinical relevance
研究组 & 干预措施
BIIL 284 BS with high fat meal
Experimental
干预措施: BIIL 284 BS (Drug)
BIIL 284 BS fasted
Active Comparator
干预措施: BIIL 284 BS (Drug)
BIIL 284 BS with high fat meal
Experimental
干预措施: high fat meal (Other)
BIIL 284 BS with low fat meal
Experimental
干预措施: BIIL 284 BS (Drug)
BIIL 284 BS with low fat meal
Experimental
干预措施: low fat meal (Other)
结局指标
主要结局
Maximum concentration (Cmax)
时间窗: up to 72 hours after drug administration
Area under the concentration time curve from timepoint zero extrapolated to infinity (AUC-infinity)
时间窗: up to 72 hours after drug administration
次要结局
- Total mean residence time (MRTtot)(up to 72 hours after drug administration)
- Time to Cmax (tmax)(up to 72 hours after drug administration)
- Area under the concentration time curve from timepoint zero to time of last data point above limit of quantification (AUC-tz)(up to 72 hours after drug administration)
- Volume of distribution during terminal phase after oral administration (Vz/F)(up to 72 hours after drug administration)
- Total clearance after oral administration (CLtot/F)(up to 72 hours after drug administration)
- Terminal half-life (t1/2)(up to 72 hours after drug administration)
- Number of subjects with adverse events(up to 8 days after last drug administration)
- Number of subjects with clinically significant findings in vital functions(up to 8 days after last drug administration)
- Number of subjects with clinically significant findings in laboratory tests(up to 8 days after last drug administration)
研究者
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