A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers

January 2, 2012 updated by: Boryung Pharmaceutical Co., Ltd
To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

<Hepatic impairment patient>

  • age: 20 - 64 years
  • sex: male
  • Child-Pugh score A or Child-Pugh score B
  • body weight: greater than 55 kg
  • written informed consent

<Healthy volunteer>

  • age: 20 - 64 years
  • sex: male
  • body weight: greater than 55 kg
  • written informed consent

Exclusion Criteria:

<Hepatic impairment patient>

  • portosystemic shunt surgery
  • Child-Pugh score C
  • creatinine clearance < 80mL/min
  • ascites

<Healthy volunteer>

  • AST(SGOT), ALT(SGPT) > 1.5 times of Upper Normal Range
  • Total bilirubin > 1.5 times of Upper Normal Range
  • positive drug or alcohol screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hepatic impairment patients
Hepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C)
Drug: fimasartan
single administration of fimasartan 120mg
Active Comparator: Healthy volunteers
healthy volunteers group
Drug: fimasartan
single administration of fimasartan 120mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic characteristics of fimasartan
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h
AUC, Cmax, Tmax, T1/2, CL/F of fimasartan
0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Collaborators

Yonsei University
Kyungpook National University Hospital

Investigators

  • Principal Investigator: Minsoo Park, PhD, Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 17, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 2, 2012

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A657-BR-CT-112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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