Status:
COMPLETED
Bioavailability of Oral BIRB 796 BS Tablets With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS. Safety and tolerability were also assessed.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02209831
Start Date
November 1 2001
Last Update
August 6 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.