Status:
COMPLETED
Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a standard breakfas...
Eligibility Criteria
Inclusion
- All participants are healthy males
- Age range from 21 to 50 years
- Broca-Index: within +- 20% of normal weight
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 with psychiatric 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 a drug with a long half-life (\> 24 hours) within one month or less than ten half-lives of the respective drug before enrollment 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 study with an investigational drug (\>= tow months prior to administration or during the trial)
- Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse (\> 60g/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 :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02265640
Start Date
October 1 2000
Last Update
October 16 2014
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