Healthy
Conditions
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 breakfast in healthy male volunteers
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma levels of BIIL 315 ZW | up to 72 hours after drug administration |
| AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 72 hours after drug administration |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 72 hours after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | up to 72 hours after drug administration | — |
| CLtot/F (Total clearance after oral administration) | up to 72 hours after drug administration | — |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 72 hours after 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 | — |
| Number of subjects with adverse events | up to 8 days after last drug administration | — |
| t½ (Terminal half-life of the analyte in plasma) | up to 72 hours after drug administration | — |
| MRTtot (Total mean residence time) | up to 72 hours after drug administration | — |
Outcome results
None listed