Healthy
Conditions
Brief summary
Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)
Interventions
DRUGBIBP 5371 CL tablet
single rising daily doses
DRUGBIBP 5371 CL solution
OTHERHigh fat, high caloric breakfast
DRUGPlacebo tablet
DRUGBIBP 5371 CL tablet high dose
DRUGPlacebo drinking solution
DRUGBIBP 5371 CL tablet low dose
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female volunteers * Age 21 - 50 years * Body mass index (BMI) 18.5 - 29.9 kg/m2
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate, respiratory rate, body temperature and ECG) deviating from normal * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system or psychiatric disorders or neurological disorders * History of relevant 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 1 month or less than 10 half-lives of the respective drug before enrolment in the study * Use of any drugs which might influence the results of the trial (within 1 week prior to administration or during the trial) * Participation in another trial with an investigational drug (within 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 trial days * Alcohol abuse (\> 60 grams/day) * Drug abuse * Blood donation (≥ 100 mL within 4 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 In addition, for female subjects: * Pregnancy * Positive pregnancy test * No adequate contraception e.g. oral contraceptives, intrauterine device, sterilisation Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 1 month after release from the study * Inability to maintain this adequate contraception during the whole study period * Lactation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with changes in vital signs | baseline, up to 8 days after drug administration | blood pressure, pulse rate, respiratory rate, body temperature |
| Number of patients with changes in electrocardiogram (ECG) | baseline, up to 8 days after drug administration | — |
| Number of patients with changes in safety laboratory parameters | baseline, up to 8 days after drug administration | — |
| Number of patients with adverse events | baseline, up to 8 days after drug administration | — |
| Global tolerability assessment by the investigator on a verbal rating scale | up to 8 days after drug administration | — |
Secondary
| 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 32 hours after drug administration |
| %AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation) | up to 32 hours after drug administration |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | up to 32 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 32 hours after drug administration |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | up to 32 hours after drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 32 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 32 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 32 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 32 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after po administration) | up to 32 hours after drug administration |
| Cmax (maximum concentration of the analyte in plasma) | up to 32 hours after drug administration |
| tmax (time from dosing to maximum concentration) | up to 32 hours after drug administration |
Outcome results
None listed