Status:
COMPLETED
Effect of Different Food Compositions on Bioavailability of BIIL 284 BS in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
food effect, relative bioavailability, pharmacokinetics, safety and tolerability
Eligibility Criteria
Inclusion
- All participants in the study should be healthy caucasian males as determined by the results of screening, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index)
- All volunteers will have given their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study
Exclusion
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial (\<= one week prior to administration or during the trial)
- Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial)
- Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (\> 60 g/day)
- Drug abuse
- Blood donation (\>= 100 ml within four weeks prior to administration or during the trial)
- Excessive physical activities (within the last week before the study)
- Any laboratory value outside the reference range of clinical relevance
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02273427
Start Date
February 1 2000
Last Update
October 24 2014
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