NCT02223000已完成1 期
Relative Bioavailability and Tolerability of Various Experimental Formulations of 50 mg BIBV 308 SE Administered Orally Twice a Day Over 3.5 Days to Healthy Subjects (Intraindividual Comparison, Open, Partially Randomised).
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
- 9
- 主要终点
- Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss)
研究概览
简要总结
Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral solution of BIBV 308 SE following multiple doses, tolerability
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects that were previously entered in at least one BIBV 308 SE study to ensure that it is known how these subjects absorb BIBV 308 SE
- •Healthy subjects as determined by results of screening
- •Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- •Age >= 18 and <= 55 years
- •Broca >= -20% and <= +20 %
排除标准
- •Poor individual absorption kinetics of BIBV 308 SE in previous studies
- •Any findings 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 the gastro-intestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- •Chronic or relevant acute infections
- •Hypersensitivity to BIBV 308 SE and any of the excipients
- •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 days 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
- •Known alcohol or drug abuse
- •Blood donation <= 1 month prior to administration
- •Excessive physical activities <= 5 days prior to administration
- •History of hemorrhagic diathesis
- •History of gastro-intestinal ulcer, perforation or bleeding
- •History of bronchial asthma
- •Any laboratory value outside the reference range of clinical relevance
研究组 & 干预措施
BIBV 308 SE capsule 1
Experimental
干预措施: BIBV 308 SE capsule 1 (Drug)
BIBV 308 SE solution
Active Comparator
干预措施: BIBV 308 SE solution (Drug)
BIBV 308 SE capsule 2
Experimental
干预措施: BIBV 308 SE capsule 2 (Drug)
结局指标
主要结局
Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss)
时间窗: up to 84 hours after drug administration
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
时间窗: up to 84 hours after drug administration
Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
时间窗: up to 84 hours after drug administration
次要结局
- Mean residence time of the analyte in the body (MRTtot)(up to 84 hours after drug administration)
- Ratio of Cmax,ss/AUCss(up to 84 hours after drug administration)
- Apparent clearance of the analyte in plasma (CL/f)(up to 84 hours after drug administration)
- Trough concentrations of BIBV 308 SE before doses(up to day 4)
- Percent peak-trough fluctuation (%PTF)(up to 84 hours after drug administration)
- Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)(up to 84 hours after drug administration)
研究者
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