Status:
COMPLETED
Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the su...
Eligibility Criteria
Inclusion
- Healthy male subjects as determined by results of screening
- Age ≥ 21 and ≤ 50 years
- Broca ≥ - 20% and ≤ + 20%
- Signed written informed consent in accordance with Good Clinical Practice and local legislation
Exclusion
- Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values
- Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- Known 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 a drug 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
- Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study
- Participation in another study with an investigational drug within the last two months preceding this study
- Smokers (\> 5 cigarettes or 2 cigars or 2 pipes/day)
- Volunteer who is not able to refrain from smoking on study days
- Alcohol abuse (more than 60 g of alcohol per day)
- Drug abuse
- Excessive physical activities (e.g. competitive sports) within the last week before the study
- Blood donation within the last 4 weeks (≥ 100 ml)
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT02265302
Start Date
June 1 1998
Last Update
October 15 2014
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