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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014