Randomised 3-way Cross-over Phase I Study to Investigate the Relative Bioavailability of BIIL 284 BS 75 mg Tablet C and Tablet D in Comparison to WIF Tablet in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 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 two BIIL 284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg following 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 their 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
- •Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- •Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- •Volunteers with history of orthostatic hypotension, fainting spells or blackouts
- •Volunteers with chronic or relevant acute infections
- •Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Volunteers who have taken a drug with a long half-life (>= 24 hours) within one month or less than ten half-lives of the respective drug before enrollment in the study
- •Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
- •Volunteers who participated in another study with an investigational drug within the last two months preceding this study
- •Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
- •Volunteers who drink more than 60g of alcohol per day
- •Volunteers who are dependent on drugs
- •Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
- •Volunteers who have donated blood within the last 4 weeks (>= 100 mL)
研究组 & 干预措施
BIIL 284 BS tablet C
干预措施: BIIL 284 BS tablet C (Drug)
BIIL 284 BS tablet D
干预措施: BIIL 284 BS tablet D (Drug)
BIIL 284 BS WIF tablet
干预措施: BIIL 284 BS WIF tablet (Drug)
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 72 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
时间窗: up to 72 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
时间窗: up to 72 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
时间窗: up to 72 hours after drug administration
MRTtot (Total mean residence time)
时间窗: up to 72 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
时间窗: up to 72 hours after drug administration
CLtot/F (Total clearance after oral administration)
时间窗: up to 72 hours after drug administration
次要结局
- Number of subjects with adverse events(up to 8 days after last drug administration)
- Number of subjects with clinically findings in vital functions(up to 8 days after last drug administration)
- Number of subjects with clinically findings in laboratory tests(up to 8 days after last drug administration)