Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects

Boryung

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Fimasartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01671020

A657-BR-CT-115

Details and patient eligibility

About

Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb® tablet (fimasartan) in healthy subjects

Enrollment

16 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

age: 20 - 55 years
body weight: standard weight(Broca's index, Possible range is plus or minus 20percent)
written informed consent

Exclusion criteria

known allergy to Fimasartan
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
abnormal diet which could affect drug absorption or metabolism
positive drug or alcohol screening
smokers of 10 or more cigarettes per day
participation in a clinical trial during the last 90 days prior to the start of the study