Healthy
Conditions
Brief summary
To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules
Interventions
DRUGBIBB 515 BS
OTHERStandard breakfast (40 g fat)
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male caucasian subjects as determined by results of screening * Written informed consent in accordance with good clinical practice (GCP) and local legislation * Age ≥ 18 and ≤ 50 years * Broca ≥ - 20 % and ≤ + 20 %
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 * Surgery of gastrointestinal tract (except appendectomy) * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic 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 drugs with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial) * Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial) * Participation in another trial with an investigational drug (≤ 2 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 (\> 60 g/day) * Drug abuse * Blood donation \> 100 ml (≤ 4 weeks prior to administration or during the trial) * Excessive physical activities (≤ 10 days prior to administration or during the trial) * Any laboratory value outside the reference range of clinical relevance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration of the analyte in plasma (Cmax) | Up to 48 hours after drug administration |
| Time to reach maximum concentration of the analyte in plasma (tmax) | Up to 48 hours after drug administration |
| Apparent terminal elimination half-life of the analyte in plasma (t1/2) | Up to 48 hours after drug administration |
| Area under the concentration-time curve of the analyte in plasma at different time points (AUC) | Up to 48 hours after drug administration |
| Total mean residence time of the analyte in the body (MRTtot) | Up to 48 hours after drug administration |
| Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/f) | Up to 48 hours after drug administration |
| Apparent volume of distribution of the analyte during the terminal phase (Vz/f) | Up to 48 hours after drug administration |
| Terminal rate constant of the analyte in plasma (λz) | Up to 48 hours after drug administration |
| Number of patients with adverse events | Up to 48 hours after last drug administration |
| Global clinical assessment by the investigator | Day 3 after last drug administration |
Outcome results
None listed