Healthy
Conditions
Brief summary
Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS. Safety and tolerability were also assessed.
Interventions
DEVICEBIBR 796 BS
single dose
DRUGPantoprazole
5 days
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.) | up to 36 hours after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric pH measurements | up to 12 hours after drug administration | — |
| Number of patients with adverse events | up to 34 days | — |
| Maximum observed plasma concentration (Cmax) | up to 36 hours after drug administration | — |
| Area under the plasma concentration versus time curve over a given time interval (AUC0-t) | up to 36 hours after drug administration | — |
| Mean residence time (MRT) | up to 36 hours after drug administration | — |
| Apparent oral clearance (CL/F) | up to 36 hours after drug administration | — |
| Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F) | up to 36 hours after drug administration | — |
| Elimination half-life (t1/2) | up to 36 hours after drug administration | — |
| Assessment of tolerability | on the last 1 day of second treatment | based on the ability of the subjects to take the medicine as well as occurence of adverse events and abnormal laboratory investigations |
| Time to the maximum plasma concentration (tmax) | up to 36 hours after drug administration | — |
Outcome results
None listed