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Completed

NCT Number: NCT01146938

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

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

Completed

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hepatic Impairment Hypertension Vascular Diseases

Age range

20 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fimasartan

Drug

single administration of fimasartan 120mg

Primary outcomes

  1. 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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Collaborators

  • Kyungpook National University Hospital
  • Yonsei University

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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