Bioavailability of Ibuprofen Enantiomers Compared With Standard Brufen Sirup in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Brufen syrup; Drug: Ibuprofen syrup

• Registration Number: NCT02182960
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Pharmacokinetics (relative bioavailability), safety and tolerability

Detailed Description

Not available

Study Timeline

• Study Start: 1998-09
• Primary Completion: 1998-10
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Brufen	Brufen syrup	-
Ibuprofen	Ibuprofen syrup	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to reach the maximum concentration of the analyte in plasma (tmax)	Up to 12 hours after each administration
Apparent terminal rate constant (λz)	Up to 12 hours after each administration
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
Number of adverse events	Up to 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
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
Change from baseline in 12-lead ECG (electrocardiogram)	Baseline, 8 days after last drug administration