A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.

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

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Treatments: Ketoconazole; Rifampin

Criteria

Inclusion Criteria:

• age: 20 - 45 years

• sex: male

• body weight: greater than 55 kg

• written informed consent

Exclusion Criteria:

• known allergy to Fimasartan, ketoconazole and rifampicin

• existing cardiac or hematological diseases

• existing hepatic and renal diseases

• existing gastrointestinal diseases

• acute or chronic diseases which could affect drug absorption or metabolism

• history of any serious psychological disorder

• positive drug or alcohol screening

• smokers of 10 or more cigarettes per day 3 month ago

• participation in a clinical trial during the last 2 months prior to the start of the study