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

This study has been completed.
Sponsor:
Collaborators:
Kyungpook National University
Yonsei University
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01146938
First received: June 17, 2010
Last updated: January 2, 2012
Last verified: December 2010
  Purpose

To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers


Condition Intervention Phase
Essential Hypertension
Hepatic Impairment
Drug: fimasartan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    AUC, Cmax, Tmax, T1/2, CL/F of fimasartan


Estimated Enrollment: 18
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146938

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Kyungpook National University
Yonsei University
Investigators
Principal Investigator: Minsoo Park, PhD Yonsei University
  More Information

No publications provided by Boryung Pharmaceutical Co., Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01146938     History of Changes
Other Study ID Numbers: A657-BR-CT-112
Study First Received: June 17, 2010
Last Updated: January 2, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Boryung Pharmaceutical Co., Ltd:
fimasartan
hepatic impairment

Additional relevant MeSH terms:
Hypertension
Liver Diseases
Vascular Diseases
Cardiovascular Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014