Bioavailability of BIBR 1048 MS Single Doses With or Without Pantoprazole in Healthy Subjects

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

Summary

The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule formulation using melt extrusion technology was assessed in two separate, single dose, 3-way crossover, open design, randomised studies. The 3-way crossover treatments included administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A or B and administration of the capsules with coadministration of pantoprazole.

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

Details

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

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 ≤ 55 years

• Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria:

• Any findings 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 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