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

NCT ID: NCT02170623

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28

Brief Summary

Study to assess the amount of BIBR 953 ZW in urine and concentrations in plasma after administration of 50 mg of BIBR 1048 bid over three days each administered as two experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Period 1: BIBR 1048 MS with Pantoprazole

Three treatments of different formulations of 50 mg BIBR 1048 MS (bid for 3 days) with 40 mg Pantoprazole (bid). Randomised sequence.

1. BIBR 1048 MS Capsule I with pantoprazole (bid for 3 days);

2. BIBR 1048 MS Capsule K with pantoprazole (bid for 3 days);

3. BIBR 1048 MS Drinking solution with Pantoprazole (bid for 3 days)

Group Type: EXPERIMENTAL

BIBR 1048 MS Capsule I

Intervention Type: DRUG

25 mg BIBR 1048 MS

BIBR 1048 MS Capsule K

Intervention Type: DRUG

50 mg BIBR 1048 MS

Pantoprazole

Intervention Type: DRUG

40 mg pantoprazole

BIBR 1048 MS drinking solution

Intervention Type: DRUG

50 mg BIBR 1048 MS powder plus solution

Period 2: BIBR 1048 MS

Three treatments of different formulations of 50 mg BIBR 1048 MS (bid for 3 days) without Pantoprazole. Fixed sequence.

1. BIBR 1048 MS Capsule K (bid for 3 days);

2. BIBR 1048 MS Drinking solution (bid for 3 days)

Group Type: EXPERIMENTAL

BIBR 1048 MS Capsule K

Intervention Type: DRUG

50 mg BIBR 1048 MS

BIBR 1048 MS drinking solution

Intervention Type: DRUG

50 mg BIBR 1048 MS powder plus solution

Interventions

BIBR 1048 MS Capsule I

25 mg BIBR 1048 MS

Intervention Type: DRUG

BIBR 1048 MS Capsule K

50 mg BIBR 1048 MS

Intervention Type: DRUG

Pantoprazole

40 mg pantoprazole

Intervention Type: DRUG

BIBR 1048 MS drinking solution

50 mg BIBR 1048 MS powder plus solution

Intervention Type: DRUG

Eligibility 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
• 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
• History of or current 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)
• commotio cerebri
• 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.33

Identifier Type: -

Identifier Source: org_study_id