NCT02171715已完成1 期
Relative Bioavailability of a Single Dose 20 mg BIBW 2992 Administered as Tablet (Final Formulation) Compared to BIBW 2992 Drinking Solution and BIBW 2992 Tablet (Trial Formulation II) Following Oral Administration to Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Three-way Crossover Phase I Study)
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
- 22
- 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 primary objective of the study was to investigate the relative bioavailability and pharmacokinetics of 20 mg BIBW 2992 administered as film-coated immediate release tablet (final formulation, i.e. phase III/to-be-marketed formulation) to healthy subjects in comparison with the drinking solution and in comparison with the trial formulation II tablet, which was administered in phase II clinical trials and also partly in phase I trials.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males according to a complete medical history, including a physical examination, vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram), and clinical laboratory tests
- •Age 21 to 55 years, inclusive
- •Body mass index 18.5 to 29.9 kg/m2, inclusive
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
排除标准
- •Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- •Any evidence of a clinically relevant concomitant disease
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of the 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 relevant allergy/hypersensitivity (including drug allergy or its excipients)
- •Intake of drugs with a long half-life (> 24 hours) within one month prior to administration of the trial drug or during the trial
- •Use of any drugs (including herbal preparations, vitamins and nutrient supplements) within 10 days prior to first administration of the trial drug 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 within the in-house periods from 12 hours before until 25 hours after each administration of the trial drug
- •Alcohol abuse (more than 60 g/day)
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks prior to administration of the trial drug or during the trial)
- •Excessive physical activities (within one week prior to administration of the trial drug or during the trial)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of trial site
- •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- •A history of additional risk factors for Torsades de Points, e.g., heart failure, hypokalemia, family history of Long QT Syndrome
- •Exclusion criteria specific for this study:
- •Total bilirubin greater than 1.5 mg/dL
- •History of clinically relevant skin diseases, psoriasis or moderate/severe acne
- •Female gender
- •Male subjects who refuse to minimise the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or another medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intrauterine device, tubal ligation, hormonal contraceptive for at least two months, or diaphragm with spermicide
研究组 & 干预措施
BIBW 2992 MA2, final formulation
Experimental
干预措施: BIBW 2992 MA2 (Drug)
BIBW 2992 MA2, trial formulation II
Experimental
干预措施: BIBW 2992 MA2 (Drug)
BIBW 2992 MA 2 drinking solution
Active Comparator
干预措施: BIBW 2992 MA2 (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 96 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: up to 96 hours after drug administration
次要结局
- AUC (area under the concentration-time curve of the analyte in plasma) for several time points(up to 96 hours after drug administration)
- CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(up to 96 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(up to 96 hours after drug administration)
- Number of patients with adverse events(up to 88 days)
- Assessment of tolerability by the investigator on a 4-point scale(Day 5 of each treatment period)
- %AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation from the last quantifiable data point to infinity)(up to 96 hours after drug administration)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(up to 96 hours after drug administration)
- λz (terminal rate constant in plasma)(up to 96 hours after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(up to 96 hours after drug administration)
- MRTpo (mean residence time of the analyte in the body after oral administration)(up to 96 hours after drug administration)
研究者
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