NCT Number: NCT02182960
Bioavailability of Ibuprofen Enantiomers Compared With Standard Brufen Sirup in Healthy Male Volunteers
Pharmacokinetics (relative bioavailability), safety and tolerability
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Conditions
Age range
21 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Brufen syrup
DrugPrimary outcomes
-
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)
Time frame: Up to 12 hours after each administration
-
Maximum drug plasma concentration (Cmax)
Time frame: Up to 12 hours after each administration
Secondary outcomes
-
Time to reach the maximum concentration of the analyte in plasma (tmax)
Time frame: Up to 12 hours after each administration
-
Apparent terminal rate constant (λz)
Time frame: Up to 12 hours after each administration
-
Apparent terminal half-life of the analyte in plasma (t1/2)
Time frame: 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))
Time frame: Up to 12 hours after each administration
-
Mean residence time, total (MRTtot)
Time frame: Up to 12 hours after each administration
-
Total plasma clearance divided by the systemic availability factor (CL/f)
Time frame: Up to 12 hours after each administration
-
Volume of distribution during the terminal phase λz, divided by f (Vz/f)
Time frame: Up to 12 hours after each administration
-
Number of adverse events
Time frame: Up to 8 days after last drug administration
-
Change from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline, 8 days after last drug administration
-
Change in vital functions (blood pressure and puls rate)
Time frame: Baseline, up to 8 days after last drug administration
-
Change from baseline in standard laboratory evaluation
Time frame: Baseline, 8 days after last drug administration
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
An Open Two Way Cross Over Study to Relative Bioavailability of Ibuprofen Enantiomers After Single p.o. Administration of 200 mg Syrup (T) Compared With 200 mg Standard Brufen Sirup (R)
Important dates
- Study start
- 1998
- Primary completion
- 1998
- First posted
- Jul 8, 2014
- Registry last updated
- Aug 31, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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