Bioavailability of Oral BIRB 796 BS Tablets With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers

NCT ID: NCT02209831

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30

Brief Summary

Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.

Safety and tolerability were also assessed.

Conditions

Healthy

Study Design

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

Study Groups

BIBR 796 BS + pantoprazole

Group Type: EXPERIMENTAL

BIBR 796 BS

Intervention Type: DEVICE

single dose

Pantoprazole

Intervention Type: DRUG

5 days

BIBR 796 BS without pantoprazole

Group Type: ACTIVE_COMPARATOR

BIBR 796 BS

Intervention Type: DEVICE

single dose

Interventions

BIBR 796 BS

single dose

Intervention Type: DEVICE

Pantoprazole

5 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age >=18 and <=55 years
• Laboratory examinations within a clinically defined reference range
• Helicobacter pylori negative
• Able to tolerate pH probe application
• Body mass index (BMI) >=18.5 and <=29.9 kg/m2

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• Surgery of gastrointestinal tract (excluding appendectomy)
• History of orthostatic hypotension, fainting spells or blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 including study drugs
• History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
• Intake of drugs with a long half-life (> 24 hours) within 1 month or 10 half lives of that drug, whichever is longer, prior to administration of study drugs or during the trial
• Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
• Use of grapefruit or grapefruit juice, alcohol, green tea, methylxanthine-containing products or tobacco within 5 days of study drug administration
• Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
• Smoker
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood or plasma donation (>400 ml) within 1 month prior to administration or during trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Following specific laboratory findings: aspartate aminotransferase, alanine transaminase, Gamma-glutamyl-transferase above the reference range
• Inability to comply with dietary regimen of study centre
• Inability to comply with investigator's instructions

• 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

Related Links

http://clintriage.rdg@boehringer-ingelheim.com

Related Info

Other Identifiers

1175.17

Identifier Type: -

Identifier Source: org_study_id