Single-dose Pharmacokinetics of 160 mg BIBX 245 CL and Effect of Food After Oral Administration of Tablets to Healthy Subjects (Randomized, 2-way-cross-over, Open Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Cmax (Maximum measured concentration of the analyte in plasma)
研究概览
简要总结
Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety
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
- •Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- •Age >= 18 and <= 50 years
- •Broca >= -20% and <= +20%
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic 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) (<= 1 month prior to administration or during the trial)
- •Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
- •Participation in another trial with an investigational drug (<= 2 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 (> 60 g/day)
- •Drug abuse
- •Blood donation > 100 ml (<= 4 weeks prior to administration or during the trial)
- •Excessive physical activities (<= 10 days prior to administration or during the trial)
- •Any laboratory value outside the reference range or clinical relevance
研究组 & 干预措施
BIBX 245 CL - fed
after a light breakfast with 40 g fat
干预措施: BIBX 245 CL - fed (Drug)
BIBX 245 CL - fasted
干预措施: BIBX 245 CL- fasted (Drug)
结局指标
主要结局
Cmax (Maximum measured concentration of the analyte in plasma)
时间窗: up to 24 hours post dose
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
时间窗: up to 24 hours post dose
MRTtot (Mean residence time)
时间窗: up to 24 hours post dose
t½ (Terminal half-life of the analyte in plasma)
时间窗: up to 24 hours post dose
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 post dose
λz (Terminal rate constant in plasma)
时间窗: up to 24 hours post dose
次要结局
- Number of subjects with adverse events(up to 20 days)
- Assessment of tolerability by investigator(after 20 days)