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

Randomised 3-way Cross-over Phase I Study to Investigate the Relative Bioavailability of BIIL 284 BS 75 mg Tablet C and Tablet D in Comparison to WIF Tablet in Healthy Volunteers

The objective of the present study is to investigate the relative bioavailability of two BIIL 284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg following 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 their normal weight
• In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study

Exclusion Criteria:

• Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
• Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
• Volunteers with history of orthostatic hypotension, fainting spells or blackouts
• Volunteers with chronic or relevant acute infections
• Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Volunteers who have taken 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
• Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
• Volunteers who participated in another study with an investigational drug within the last two months preceding this study
• Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
• Volunteers who drink more than 60g of alcohol per day
• Volunteers who are dependent on drugs
• Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
• Volunteers who have donated blood within the last 4 weeks (>= 100 mL)