Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS

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

Summary

To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Ranitidine; Ranitidine bismuth citrate

Criteria

Inclusion Criteria:

• healthy male subjects as determined by results of screening

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

• age >= 18 and <= 50 years

• Broca >= - 20% and <0 + 20%

Exclusion Criteria:

• any finding of the medical examination (including blood pressure, pulse rate and ECG)

• history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders

• history of orthostatic hypotension, fainting spells and blackouts

• diseases of 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 administration

• participation in another trial with an investigational drug within 2 month 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