Study to Investigate the Effect of Ketoconazole Mediated CYP3A4 Inhibition on Pharmacokinetics of Tamsulosin in Healthy Male Volunteers

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

Summary

Study to investigate the effect of CYP3A4 inhibition by ketoconazole on the single oral dose pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Ketoconazole; Tamsulosin

Criteria

Inclusion Criteria:

All participants in the study will be

• Healthy males

• Ranging from 21 to 50 years of age

• Body mass index (BMI) within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)

• In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances

• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

• History of orthostatic hypotension, fainting spells or blackouts

• Chronic or clinically relevant acute infections

• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator

• Intake of drugs with a long half-life (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study

• Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study

• Participation in another trial with an investigational drug (within two months prior to administration or during the trial)

• Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)

• Inability to refrain from smoking on trial days

• Alcohol abuse (> 60 g/day)

• Drug abuse

• Blood donation (> 100 mL within four weeks prior to administration or during the trial)

• Any laboratory value outside the reference range if indicative of underlying disease or poor health

• Excessive physical activities within the last week before the trial or during the trial

• Hypersensitivity to treatment medication and/or related drugs of these classes

• Non extensive metabolizer (EM) for CYP2D6