NCT02182193已完成1 期
Safety and Relative Bioavailability of a Single Dose of 150 mg BIBF 1120 Administered as Soft Gelatine Capsules Charge 1 Compared to BIBF 1120 Soft Gelatine Capsules Charge 2 Compared to BIBF 1120 Administered as Drinking Solution Following Oral Administration to Healthy Male Volunteers in an Open, Randomised, Intra-individual, Crossover Comparison Design
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Area under the plasma concentration-time curve of the analyte from zero time (pre-dose) extrapolated to infinity (AUC0-∞)
研究概览
简要总结
To assess pharmacokinetics and the relative bioavailability of a single dose of BIBF 1120 soft gelatine capsule charge 1 vs. BIBF 1120 soft gelatine capsule charge 2 vs BIBF 1120 drinking solution in healthy male subjects respectively. To establish an in-vitro-in-vivo correlation (IVIVC) for oral soft gelatine capsules with 150 mg BIBF 1120 in healthy male volunteers (if feasible)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 male subjects as determined by results of screening
- •Signed written informed consent in accordance with GCP and local legislation
- •Age ≥21 and ≤55 years
- •Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- •History of relevant orthostatic hypotension, fainting spells and blackouts
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy or its excipients) which is deemed relevant to the trial as judged by the investigator
- •History of any bleeding disorder including prolonged or habitual bleeding, other hematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri
- •Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- •Use of any drugs which might influence the results of the trial within 14 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within 2 months prior to administration or during trial
- •Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- •Alcohol abuse (> 60 g/day)
- •Blood donation (more than 150 mL within 4 weeks prior to administration or during the trial)
- •Excessive physical activities within 5 days prior to administration or during the trial
- •Any laboratory value outside the reference range that is of clinical relevance
- •Female gender
- •Male subjects refuse to minimize 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 a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide
研究组 & 干预措施
BIBF 1120 capsules charge 1
Experimental
干预措施: BIBF 1120 capsules charge 1 (Drug)
BIBF 1120 capsules charge 2
Experimental
干预措施: BIBF 1120 capsules charge 2 (Drug)
BIBF 1120 drinking solution
Active Comparator
干预措施: BIBF 1120 drinking solution (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve of the analyte from zero time (pre-dose) extrapolated to infinity (AUC0-∞)
时间窗: 1 h pre dose and up to 48 h after drug administration
Individual maximum observed concentrations of the analyte in plasma (Cmax)
时间窗: 1 h pre dose and up to 48 h after drug administration
次要结局
- Area under the plasma concentration-time curve of the analyte over the time interval from time zero (pre-dose) to 24 hours (AUC0-24)(1 h pre dose and up to 24 h after drug administration)
- time from dosing to the maximum concentration of the analyte in plasma (tmax)(1 h pre dose and up to 48 h after drug administration)
- Terminal rate constant in plasma (λz)(1 h pre dose and up to 48 h after drug administration)
- Terminal half-life of the analyte in plasma (t1/2)(1 h pre dose and up to 48 h after drug administration)
- Mean residence time of the analyte in the body after oral administration (MRTpo)(1 h pre dose and up to 48 h after drug administration)
- Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)(1 h pre dose and up to 48 h after drug administration)
- Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)(1 h pre dose and up to 48 h after drug administration)
- Change in vital signs (blood pressure, pulse rate)(Baseline, up to 24 hours after drug administration)
- Change in routine laboratory values(pre-dose, up to 48 hours after drug administration)
- Change in ECG(pre-dose, 4 hours after drug administration, day 32)
- Occurrence of adverse events(up to 32 days after drug administration)
- Assessment of tolerability by investigator on a 4 point scale(48 hours after drug administration)
研究者
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