Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers

Randomised 4-way Cross-over Phase I Study to Investigate the Relative Bioavailability of BIIL 284 BS 75 mg Boli in Comparison to Tablet C in Fasted Condition and After Ingestion of a Standardised Meal in Healthy Volunteers

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 breakfast in healthy male volunteers

Inclusion Criteria:

• All participants are healthy males
• Age range from 21 to 50 years
• Broca-Index: within +- 20% of normal weight

Exclusion Criteria:

• 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