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

Study Overview
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Brief Summary
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Pharmacokinetics (relative bioavailability), safety and tolerability

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ibuprofen syrup
* Drug: Brufen syrup


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br> | Drug: Ibuprofen syrup<br> <br> |
| Active Comparator: Brufen<br> | Drug: Brufen syrup<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Volume of distribution during the terminal phase λz, divided by f (Vz/f) |  | 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 |