NCT02265666已完成1 期
Randomised, Open-label, Two-way Crossover Study in Male Healthy Volunteers to Investigate the Relative Bioavailability of BIIL 284 BS 5 mg Tablet FF in Comparison to Tablet C After Ingestion of a Standardised Meal
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
- AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
研究概览
简要总结
The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in healthy male volunteers
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 are healthy males
- •Age range from 21 to 50 years
- •Broca-Index: within +- 20% of normal weight
- •In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent 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 with psychiatric 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 a drug with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrollment 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 study days
- •Alcohol abuse (> 60g/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 Tablet FF
Experimental
干预措施: BIIL 284 BS Tablet FF (Drug)
BIIL 284 BS Tablet FF
Experimental
干预措施: standard breakfast (Other)
BIIL 284 BS tablet C
Active Comparator
干预措施: BIIL 284 BS tablet C (Drug)
BIIL 284 BS tablet C
Active Comparator
干预措施: standard breakfast (Other)
结局指标
主要结局
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
时间窗: up to 24 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
时间窗: up to 24 hours after drug administration
次要结局
- Terminal rate constant in plasma(up to 24 hours after drug administration)
- t½ (Terminal half-life of the analyte in plasma)(up to 24 hours after drug administration)
- AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)(up to 24 hours after drug administration)
- tmax (Time from dosing to the maximum concentration of the analyte in plasma)(up to 24 hours after drug administration)
- MRTtot (total mean residence time)(up to 24 hours after drug administration)
- CL/F (Apparent clearance of the analyte in plasma following extravascular administration)(up to 24 hours after drug administration)
- Vz/F (Apparent volume of distribution of the analyte during the terminal phase)(up to 24 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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