Healthy
Conditions
Brief summary
The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 | — |
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | 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 | — |
Outcome results
None listed