NCT00938262

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

An Open-label, Three-treatment, Three-period, One-sequence, Crossover Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Fimasartan, Ketoconazole, Rifampicin	Fimasartan (1 day) Ketoconazole (3 days) Ketoconazole + Fimasartan (1 day) Rifampicin (9 days) Rifampicin + Fimasartan (1 day)

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2009-07-13
• Last updated: 2009-10-08