Healthy
Conditions
Brief summary
Pharmacokinetics (relative bioavailability), safety and tolerability
Interventions
DRUGIbuprofen syrup
DRUGBrufen syrup
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
* Healthy males from 21 to 50 years and within +-20% of their normal weight (Broca index) * Written informed consent
Exclusion criteria
* Any findings of the medical examination or laboratory tests deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory (especially bronchial asthma and chronic obstructive pulmonary disease), cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (such as epilepsy) or psychiatric 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 a drug 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 within seven days prior to administration or during the trial * Participation in another trial with an investigational drug within two months prior to the start of the study * Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) * Inability to refrain from smoking on study days * Alcohol abuse * Drug abuse * Blood donation (\>100 ml) within four weeks prior to administration * Other disease or abnormality of clinical relevance * Excessive physical activities within two weeks prior to administration or during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞) | Up to 12 hours after each administration |
| Maximum drug plasma concentration (Cmax) | Up to 12 hours after each administration |
Secondary
| Measure | Time frame |
|---|---|
| Apparent terminal half-life of the analyte in plasma (t1/2) | Up to 12 hours after each administration |
| Total area under the plasma drug concentration-time curve from time zero to the last quantifiable drug (AUC0-t(last)) | Up to 12 hours after each administration |
| Mean residence time, total (MRTtot) | Up to 12 hours after each administration |
| Total plasma clearance divided by the systemic availability factor (CL/f) | Up to 12 hours after each administration |
| Time to reach the maximum concentration of the analyte in plasma (tmax) | Up to 12 hours after each administration |
| Number of adverse events | Up to 8 days after last drug administration |
| Change from baseline in 12-lead ECG (electrocardiogram) | Baseline, 8 days after last drug administration |
| Change in vital functions (blood pressure and puls rate) | Baseline, up to 8 days after last drug administration |
| Change from baseline in standard laboratory evaluation | Baseline, 8 days after last drug administration |
| Volume of distribution during the terminal phase λz, divided by f (Vz/f) | Up to 12 hours after each administration |
| Apparent terminal rate constant (λz) | Up to 12 hours after each administration |
Outcome results
None listed