Overview
Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Male
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Boehringer IngelheimTreatments:
DabigatranRanitidine
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