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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00938132

Enrollment

Registered

2009-07-13

Start date

2009-07-31

Completion date

2009-09-30

Last updated

2009-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

fimasartan, drug interaction

Brief summary

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

Interventions

DRUGfimasartan, warfarin

Warfarin(1d) Fimasartan(8d-16d) Fimasartan + Warfarin(11d)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
INR AUC, INRmax, INRtmax	pre-dose, 6, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026