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A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00938132
First received: July 10, 2009
Last updated: October 7, 2009
Last verified: October 2009
History of Changes
  Purpose

To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.


Condition Intervention Phase
Essential Hypertension
 Drug: fimasartan, warfarin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • INR AUC, INRmax, INRtmax [ Time Frame: pre-dose, 6, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AUClast, AUCinf, Cmax ,Tmax, CL/F of S-warfarin and R-warfarin [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: July 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fimasartan Drug: fimasartan, warfarin
Warfarin(1d) Fimasartan(8d-16d) Fimasartan + Warfarin(11d)

  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 warfarin
  • 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Choi, Director, Boryung Pharm Co., Inc.
ClinicalTrials.gov Identifier: NCT00938132     History of Changes
Other Study ID Numbers: A657-BR-CT-108
Study First Received: July 10, 2009
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Boryung Pharmaceutical Co., Ltd:
fimasartan
drug interaction

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Warfarin
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013