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

Phase 1

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Fimasartan, Ketoconazole, Rifampicin

• Registration Number: NCT00938262
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-06
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Study Completion: 2009-08
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-07
• Last Update Posted: 2009-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fimasartan, Ketoconazole, Rifampicin	Fimasartan, Ketoconazole, Rifampicin	-

Primary Outcome Measures

Name	Time	Method
Cmax, AUClast, AUCinf, CL/F, Tmax, t1/2	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, (48, 56) h