Bioavailability of BIBR 953 ZW in Healthy Subjects

NCT ID: NCT02170766

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31

Brief Summary

To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base 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

BIBR 1048 low1

Two treatments of one single dose of BIBR 1048 12.5 mg without or with Pantoprazole

1. BIBR 1048 12.5 mg without Pantoprazole

2. BIBR 1048 12.5 mg with 40 mg Pantoprazole (bid)

Group Type: EXPERIMENTAL

BIBR 1048 low1

Intervention Type: DRUG

Pantoprazole

Intervention Type: DRUG

BIBR 1048 low2

Two treatments of one single dose of BIBR 1048 25 mg without or with Pantoprazole

1. BIBR 1048 25 mg without Pantoprazole

2. BIBR 1048 25 mg with 40 mg Pantoprazole (bid)

Group Type: EXPERIMENTAL

BIBR 1048 low2

Intervention Type: DRUG

Pantoprazole

Intervention Type: DRUG

BIBR 1048 medium

Two treatments of one single dose of BIBR 1048 50 mg without or with Pantoprazole

1. BIBR 1048 50 mg without Pantoprazole

2. BIBR 1048 50 mg with 40 mg Pantoprazole (bid)

Group Type: EXPERIMENTAL

BIBR 1048 medium

Intervention Type: DRUG

Pantoprazole

Intervention Type: DRUG

BIBR 1048 high

Two treatments of one single dose of BIBR 1048 100 mg without or with Pantoprazole

1. BIBR 1048 100 mg without Pantoprazole

2. BIBR 1048 100 mg with 40 mg Pantoprazole (bid)

Group Type: EXPERIMENTAL

BIBR 1048 high

Intervention Type: DRUG

Pantoprazole

Intervention Type: DRUG

Interventions

BIBR 1048 low1

Intervention Type: DRUG

BIBR 1048 low2

Intervention Type: DRUG

BIBR 1048 medium

Intervention Type: DRUG

BIBR 1048 high

Intervention Type: DRUG

Pantoprazole

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 ≤ 50 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 of 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.15

Identifier Type: -

Identifier Source: org_study_id