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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Device: BIBR 796 BS

Drug: Pantoprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02209831

1175.17

Details and patient eligibility

About

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

Safety and tolerability were also assessed.

Enrollment

22 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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