A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00991783
First received: October 7, 2009
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.


Condition Intervention Phase
Essential Hypertension
Drug: Digoxin + Fimasartan
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Clinical Trial to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • AUC, Cmax, Tmax, CL [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24 hours at 7 day and 28 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 14
Study Start Date: August 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Digoxin + Fimasartan
    Digoxin (7 days), Digoxin + Fimasartan (7 days)
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age: 20 - 40 years
  • sex: male
  • body weight: greater than 55 kg
  • written informed consent

Exclusion Criteria:

  • known allergy to Fimasartan and digoxin
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991783

Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
Study Chair: Kyung-Sang Yu, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Choi, Director, Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00991783     History of Changes
Other Study ID Numbers: A657-BR-CT-110
Study First Received: October 7, 2009
Last Updated: November 2, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan
Drug interaction

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Digoxin
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014