Healthy
Conditions
Brief summary
Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety
Interventions
DRUGBIBX 245 CL - fed
DRUGBIBX 245 CL- fasted
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
* 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 electrocardiogram (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 or 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 post dose |
| MRTtot (Mean residence time) | up to 24 hours post dose |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 24 hours post dose |
| t½ (Terminal half-life of the analyte in plasma) | up to 24 hours post dose |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 24 hours post dose |
| λz (Terminal rate constant in plasma) | up to 24 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events | up to 20 days |
| Assessment of tolerability by investigator | after 20 days |
Outcome results
None listed