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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

Pharmacokinetics (relative bioavailability), safety and tolerability

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Ibuprofen

Criteria

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