Bioavailability of BIBR 953 ZW After Oral Administration of BIBR 1048 MS in Healthy Subjects

Condition(s) targeted: Healthy

Intervention: BIBR 1048 MS Capsule E (Drug); BIBR 1048 MS Capsule F (Drug); BIBR 1048 MS Capsule G (Drug); BIBR 1048 MS Tablet H (Drug); BIBR 1048 MS Drinking solution (Drug); Pantoprazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

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

Official title: 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).

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Total amount of BIBR 953 ZW excreted into urine over one dose interval (Ae0-12)

AUCss (area under the plasma concentration-time curve at steady state) of BIBR 953 ZW

Secondary outcome:

Cmax,ss (maximum concentration at steady state) of BIBR 953 ZW

tmax,ss (time from dosing to Cmax at steady state) of BIBR 953 ZW

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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 ≥ 18. 5 and ≤ 29. 9 kg/m2

Exclusion Criteria:

- 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

Starting date: January 2002
Last updated: June 20, 2014