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

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

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: Fimasartan, Ketoconazole, Rifampicin

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fimasartan, Ketoconazole, Rifampicin	Drug: Fimasartan, Ketoconazole, Rifampicin; Fimasartan (1 day) Ketoconazole (3 days) Ketoconazole + Fimasartan (1 day) Rifampicin (9 days) Rifampicin + Fimasartan (1 day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): October 8, 2009
• Last Update Submitted That Met QC Criteria: October 7, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Leprostatic Agents; Hormone Antagonists; Cytochrome P-450 Enzyme Inducers; Antifungal Agents; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; 14-alpha Demethylase Inhibitors; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Ketoconazole; Rifampin
• Other Study ID Numbers: A657-BR-CT-105