NCT02180503已完成1 期
Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) Reconstituted With 0.1% Tartaric Acid Compared to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers (Separately at Each Dose Level) Including the Influence of Food (Standardised High Fat Breakfast) on the Bioavailability of 10 mg BI 1356 BS as Tablet in a Single Dose, Open-label, Randomised, Two-way (1 mg) and Three-way (10 mg) Crossover 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
- 24
- 主要终点
- Cmax (maximum measured concentration of the analyte in plasma)
研究概览
简要总结
Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a food effect for the 10 mg tablet dose group
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP),Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- •No findings deviating from normal and of clinical relevance
- •No evidence of a clinically relevant concomitant disease
- •Age ≥21 and Age ≤65 years
- •BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
排除标准
- •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 neurological disorders
- •History of relevant 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 10 half-lives of the respective drug prior to administration or during the trial
- •Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within 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 (more than 60 g/day)
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- •Excessive physical activities (within one week prior to administration or during the trial)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of study centre
- •No adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until one month after the last intake
研究组 & 干预措施
BI 1356 BS - low dose
Experimental
干预措施: BI 1356 BS PIB - low dose (Drug)
BI 1356 BS - low dose
Experimental
干预措施: BI 1356 BS tablet - low dose (Drug)
BI 1356 BS - high dose
Experimental
干预措施: BI 1356 BS PIB - high dose (Drug)
BI 1356 BS - high dose
Experimental
干预措施: BI 1356 BS tablet - high dose (Drug)
BI 1356 BS - high dose
Experimental
干预措施: BI 1356 BS tablet - high dose with food (Drug)
结局指标
主要结局
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: Up to 264 h after drug administration
AUC0-infinity (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 264 h after drug administration
次要结局
- Clinically relevant changes in clinical laboratory values(Up to 18 days after last drug administration)
- AUCt1-t2 (Partial area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)(Up to 264 h after drug administration)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(Up to 264 h after drug administration)
- MRTpo (mean residence time of the analyte in the body after oral administration)(Up to 264 h after drug administration)
- λz (terminal rate constant in plasma)(Up to 264 h after drug administration)
- Assessment of tolerability by investigator on a 4-point scale(Up to 18 days after last drug administration)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(Up to 264 h after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(Up to 264 h after drug administration)
- Number of patients with adverse events(Up to 18 days after last drug administration)
- CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(Up to 264 h after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(Up to 264 h after drug administration)
研究者
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