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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
History of Changes
  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:

Drug Information available for: Digoxin
U.S. FDA Resources

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 May 23, 2013