Healthy
Conditions
Brief summary
food effect, relative bioavailability, pharmacokinetics, safety and tolerability
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 in the study should be healthy caucasian males as determined by the results of screening, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index) * All volunteers will have given their written informed consent in accordance with Good Clinical Practice and local legislation 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 psychiatric disorders or neurological 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) within at least one month or less than ten half-lives of the respective drug before enrolment 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 trial days * Alcohol abuse (\> 60 g/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 |
|---|---|
| Maximum concentration (Cmax) | up to 72 hours after drug administration |
| Area under the concentration time curve from timepoint zero extrapolated to infinity (AUC-infinity) | up to 72 hours after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal half-life (t1/2) | up to 72 hours after drug administration | — |
| Total mean residence time (MRTtot) | up to 72 hours after drug administration | — |
| Volume of distribution during terminal phase after oral administration (Vz/F) | up to 72 hours after drug administration | — |
| Time to Cmax (tmax) | up to 72 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 | — |
| Total clearance after oral administration (CLtot/F) | up to 72 hours after drug administration | — |
| Area under the concentration time curve from timepoint zero to time of last data point above limit of quantification (AUC-tz) | up to 72 hours after drug administration | — |
Outcome results
None listed