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