Healthy
Conditions
Brief summary
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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CLtot/F (Total clearance after oral administration) | up to 72 hours after 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 |
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | 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 |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 72 hours after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with clinically findings in vital functions | up to 8 days after last drug administration | blood pressure, pulse rate, ECG |
| Number of subjects with clinically 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 | — |
Outcome results
None listed