Bioavailability of BIBR 953 ZW After 50 mg of BIBR 1048 MS (Oral Prodrug of BIBR 953) in 4 Experimental Formulations Relative to Drinking Solution of BIBR 1048 MS, Each Treatment Given Bid Over 3 Days, in Healthy Subjects. Intraindividual Comparison (5-way Crossover), Randomised, Open. For Each of the 5 Treatments, Investigation of 2 Conditions: With and Without Pantoprazole (Intraindividual, Open Comparison).

Boehringer Ingelheim0 个研究点目标入组 15 人开始时间: 2002年1月最近更新: 2014年6月23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: 15
主要终点: Total amount of BIBR 953 ZW excreted into urine over one dose interval (Ae0-12)

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

Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048 bid over three days each administered as four experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole

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

•Healthy male subjects as determined by results of screening
•Signed written informed consent in accordance with GCP and local legislation
•Age ≥ 18 and ≤ 55 years
•Broca ≥ 18.5 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
•any bleeding disorder including prolonged or habitual bleeding
•other hematologic disease
•cerebral bleeding (e.g. after a car accident)
•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
•History of any familial bleeding disorder
•Thrombocytes < 150000/µl