Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of 0.25 mg, 0.75 mg, 2 mg, 6 mg, and 10 mg BIBB 1464 MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase)

Boehringer Ingelheim0 个研究点目标入组 73 人开始时间: 1999年7月最近更新: 2014年9月1日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 73
主要终点: Maximum drug plasma concentration (Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level).

Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual comparison), preliminary assessment of food effects (interindividual comparison)

Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 19 Years 至 54 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•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

•Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
•Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorder
•Surgery of the gastro-intestinal tract (except appendectomy)
•Disease 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
•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 result of the trial (<= 10 days prior to administration or during the trial)
•Participation in another trial with an investigational drug (<= 2 month 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 hemorrhagic diatheses
•History of gastro-intestinal ulcer, perforation or bleeding
•History of bronchial asthma

研究组 & 干预措施

BIBB 1464 MS single rising dose fed

Experimental

干预措施: BIBB 1464 MS tablet (Drug)

BIBB 1464 MS single rising dose fed

Experimental

干预措施: Standard dinner (Other)

BIBB 1464 MS tablet fasted

Experimental

干预措施: BIBB 1464 MS tablet (Drug)

BIBB 1464 MS solution fasted

Active Comparator

干预措施: BIBB 1464 MS solution (Drug)

BIBB 1464 MS placebo

Placebo Comparator

干预措施: BIBB 1464 MS placebo (Drug)