Relative Bioavailability, Safety and Tolerability of Two Tablet Formulations of BIIL 284 BS

Recruitment & Eligibility

Inclusion Criteria

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

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 at least 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 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 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

Study & Design

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 24 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)	up to 24 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)	up to 24 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)	up to 24 hours after drug administration
Terminal rate constant in plasma	up to 24 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)	up to 24 hours after drug administration
MRTtot (total mean residence time)	up to 24 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)	up to 24 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)	up to 24 hours after drug administration
Number of subjects with adverse events	up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital functions	up to 8 days after last drug administration	blood pressure, pulse rate, ECG
Number of subjects with clinically significant findings in laboratory tests	up to 8 days after last drug administration

Recruitment & Eligibility