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

Boryung

Status and phase: Completed; Phase 1

Conditions: Essential Hypertension

Treatments: Drug: fimasartan, warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938132

A657-BR-CT-108

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Fimasartan

Experimental group

Treatment:

Drug: fimasartan, warfarin