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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Brufen syrup

Drug: Ibuprofen syrup

Study type

Interventional

Funder types

Industry

Identifiers

1024.3

Details and patient eligibility

About

Pharmacokinetics (relative bioavailability), safety and tolerability

Enrollment

24 patients

Sex

Male

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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