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

Tracking Information
First Received Date ^ICMJE	July 10, 2009
Last Updated Date	October 7, 2009
Start Date ^ICMJE	July 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 10, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00938132 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 10, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers
Official Title ^ICMJE	A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers
Brief Summary	To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Essential Hypertension
Intervention ^ICMJE	Drug: fimasartan, warfarin Warfarin(1d) Fimasartan(8d-16d) Fimasartan + Warfarin(11d)
Study Arm (s)	Experimental: Fimasartan Intervention: Drug: fimasartan, warfarin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	15
Completion Date	September 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	20 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00938132
Other Study ID Numbers ^ICMJE	A657-BR-CT-108
Has Data Monitoring Committee	Not Provided
Responsible Party	Choi, Director, Boryung Pharm Co., Inc.
Study Sponsor ^ICMJE	Boryung Pharmaceutical Co., Ltd
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Boryung Pharmaceutical Co., Ltd
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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