A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers
- Registration Number
- NCT00938132
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fimasartan fimasartan, warfarin -
- Primary Outcome Measures
Name Time Method INR AUC, INRmax, INRtmax pre-dose, 6, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d
- Secondary Outcome Measures
Name Time Method AUClast, AUCinf, Cmax ,Tmax, CL/F of S-warfarin and R-warfarin 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