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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

July 10, 2009
October 7, 2009
July 2009
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00938132 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers
A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Essential Hypertension
Drug: fimasartan, warfarin
Warfarin(1d) Fimasartan(8d-16d) Fimasartan + Warfarin(11d)
Experimental: Fimasartan
Intervention: Drug: fimasartan, warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00938132
A657-BR-CT-108
Not Provided
Choi, Director, Boryung Pharm Co., Inc.
Boryung Pharmaceutical Co., Ltd
Not Provided
Not Provided
Boryung Pharmaceutical Co., Ltd
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP