NCT02182076已完成1 期
Safety and Pharmacokinetics/Bioavailability of a Single Dose of 150 mg BIBF 1120 Administered as Soft Gelatine Capsules With and Without Food to Healthy Male Volunteers in an Open, Randomised, Intra-individual Crossover Comparison Design
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
- 15
- 主要终点
- AUC0-∞ (area under the concentration-time curve in plasma over time from zero time extrapolated to infinity)
研究概览
简要总结
Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120 soft gelatine capsule with food effect (BA) in healthy subjects respectively.
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 male subjects as determined by results of screening
- •Signed written informed consent in accordance with GCP (Good Clinical Practice) 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 orthostatic hypotension, fainting spells and blackouts
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) 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 10 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)
- •Drug abuse
- •Blood donation within 1 month 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 clinically accepted reference range
- •Female gender
- •Male subjects must agree 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
fasted administration of BIBF 1120
Active Comparator
150 mg of BIBF 1120 ES soft gelatine capsules in fasting state
干预措施: BIBF 1120 (Drug)
fed administration of BIBF 1120
Experimental
three 50 mg BIBF 1120 soft gelatine capsule immediately after a high fat, high caloric meal
干预措施: BIBF 1120 (Drug)
结局指标
主要结局
AUC0-∞ (area under the concentration-time curve in plasma over time from zero time extrapolated to infinity)
时间窗: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Cmax (maximum observed concentration in plasma)
时间窗: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
次要结局
- Incidence and intensity of adverse events(up to 14 days)
- t1/2 (terminal half-life in plasma)(Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug)
- Changes from baseline in laboratory tests(up to 14 days)
- tmax (time from dosing to reach Cmax)(Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug)
- MRTpo (mean residence time in the body)(Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug)
- CL/F (apparent clearance in plasma following extravascular administration)(Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug)
- Vz/F (apparent volume of distribution during the terminal phase following extravascular administration)(Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug)
- Changes from baseline in vital signs (systolic and diastolic blood pressure, Pulse rate)(up to 14 days)
- Changes from baseline in 12-lead electrocardiogram(up to 14 days)
- Assessment of global tolerability on a 4-point scale(Day 3 of each treatment period)
研究者
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