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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers

NCT01146938

Essential Hypertension Hepatic Impairment

COMPLETED PHASE1

A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers

NCT03250052

Hypertension

COMPLETED PHASE1

A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers

NCT01148368

Renal Impairment

COMPLETED PHASE1

A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension

NCT00922441

Essential Hypertension

COMPLETED PHASE2

The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension

NCT01135212

Hypertension

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fimasartan

Group Type EXPERIMENTAL

fimasartan, warfarin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fimasartan, warfarin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes