NCT02223013已完成1 期
Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of 50 mg BIBV 308 SE Each, Versus a Solution of 50 mg BIBV 308 SE Administered Orally Twice a Day for 3.5 Days to Healthy Subjects (Cross-over, Open, Randomized)
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
- Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
研究概览
简要总结
Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.
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 (including thyroid) disorders
- •Surgery of the gastro-intestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- •Chronic or acute relevant infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •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 during the period of the study
- •Known alcohol (> 60 g/day) or drug abuse
- •Blood donation (<= 1 month prior to administration)
- •Excessive physical activities (<= 5 days prior to administration)
- •Any laboratory value outside the normal range of clinical relevance
- •History of haemorrhagic diathesis
- •History of gastro-intestinal ulcer, perforation or bleeding
- •History of bronchial asthma
研究组 & 干预措施
BIBV 308 SE solution
Active Comparator
干预措施: BIBV 308 SE solution (Drug)
BIBV 308 SE capsule L
Experimental
干预措施: BIBV 308 SE capsule L (Drug)
BIBV 308 SE capsule S
Experimental
干预措施: BIBV 308 SE capsule S (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
时间窗: up to 84 hours
Maximum plasma concentration at steady state (Cmax,ss)
时间窗: up to 84 hours
Minimum plasma concentration at steady state (Cmin,ss)
时间窗: up to 84 hours
次要结局
- Percent peak-to-trough fluctuation (%PTF)(up to 84 hours)
- Mean residence time in steady state (MRT,ss)(up to 84 hours)
- Time to maximum plasma concentration in steady state (tmax,ss)(up to 84 hours)
- Total plasma clearance (CL/f)(up to 84 hours)
- Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss)(up to 84 hours)
- Number of patients with adverse events(up to 5 days after last drug administration)
- Number of patients with clinically significant findings in vital signs(up to 5 days after last drug administration)
- Number of patients with clinically significant findings in laboratory tests(up to 5 days after last drug administration)
- Trough concentration of BIBV 308 SE before doses(up to 84 hours)
研究者
相似试验
已完成
1 期
Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy SubjectsHealthyNCT02223000Boehringer Ingelheim9
已完成
1 期
A Study to Compare the Bioavailability and Pharmacokinetics of Cyclosporine After Intravenous Administration of NEUROSTAT®, a CREMOPHOR® EL-free Lipid Emulsion, and SANDIMMUNE® Injection (a Suspension of Cyclosporine in CREMOPHOR® EL) in Healthy VolunteersHealthyNCT01692834NeuroVive Pharmaceutical AB65
已完成
1 期
A Pharmacokinetics and Pharmacodynamics Study Under Fasting and Fed Conditions With Paliperidone Extended-release and Immediate-release FormulationsSchizophreniaNCT00796471Johnson & Johnson Pharmaceutical Research & Development, L.L.C.35
已完成
1 期
Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305HealthyNCT00957437AstraZeneca24
已完成
1 期
Topiramate Bioequivalence Study Brazil - FastEpilepsy, Tonic-ClonicNCT01439438GlaxoSmithKline26