Overview

A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Treatments:
Digoxin
Criteria
Inclusion Criteria:

- age: 20 - 40 years

- sex: male

- body weight: greater than 55 kg

- written informed consent

Exclusion Criteria:

- known allergy to Fimasartan and digoxin

- 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