Healthy
Conditions
Brief summary
food interaction, 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 will range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-index) * written informed consent in accordance with Good Clinical Practica and local legislation
Exclusion criteria
* Subjects will be excluded from the study if the results of the medical examination or laboratory tests are judged by the investigator to differ significantly from normal clinical values * Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders * Subjects with known history of orthostatic hypotension, fainting spells or blackouts * Subjects with chronic or relevant acute infections * Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * Subjects who have taken a drug with a long half-life (\>= 24 hours) within one month before enrolment in the study * Subjects who received any other drugs which might influence the results of the trial during the week previous the start of the study * Subjects who have participated in another study with an investigational drug within the last 2 months preceding this study * Subjects who are unable to refrain from smoking on study days * Subjects who smoke more than 10 cigarettes (or 3 cigars or pipes) per day * Subjects who drink more than 60 g of alcohol per day * Subjects who are dependent on drugs * Subjects who have donated blood (\>= 100 ml) within the last 4 weeks * Subjects who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration time curve from zero to infinity (AUC0-inf) | up to 48 hours after drug administration |
| Maximum concentration of drug in plasma | up to 48 hours after drug administration |
| Time to maximum concentration (tmax) | up to 48 hours after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinically significant findings in vital signs | up to 8 days after last drug administration | blood pressure, pulse rate |
| Number of participants with clinically significant findings in ECG | up to 8 days after last drug administration | — |
| Elimination half-life (t1/2) | up to 48 hours after drug administration | — |
| Apparent volume of distribution during the terminal phase λz (Vz) | up to 48 hours after drug administration | — |
| Apparent volume of distribution after intravascular dose at steady state (Vss) | up to 48 hours after drug administration | — |
| Area under the concentration time curve from zero to to the time of last data point above limit of quantitation (AUC0-tlast) | up to 48 hours after drug administration | — |
| Cmax/AUC ratio | up to 48 hours after drug administration | — |
| Mean residence time in the body (MRTtot) | up to 48 hours after drug administration | — |
| Total clearance from plasma (CLtot) | up to 48 hours after drug administration | — |
| Number of participants with clinically significant findings in laboratory tests | up to 8 days after last drug administration | — |
| Number of participants with adverse events | up to 8 days after last drug administration | — |
Outcome results
None listed