BIBR 953 ZW in Healthy Elderly Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences. To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953 ZW.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Pantoprazole

Criteria

Inclusion Criteria:

• Healthy male and female elderly subjects as determined by results of screening

• Signed written informed consent in accordance with GCP and local legislation

• Age ≥ 65, no upper limit

• BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

• Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance

• Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders

• History of relevant 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)

• cranio-cerebral trauma

• Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration

• Use of any drugs that 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 intake (>30 - 40 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 < 140000/μl (male) or < 156000/μl (female)