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

Boryung

Status and phase: Completed; Phase 1

Conditions: Essential Hypertension

Treatments: Drug: Fimasartan, Ketoconazole, Rifampicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938262

A657-BR-CT-105

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 1 patient group

Fimasartan, Ketoconazole, Rifampicin

Experimental group

Treatment:

Drug: Fimasartan, Ketoconazole, Rifampicin