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

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)

Pharmacokinetics (relative bioavailability), safety and tolerability

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