Status:
COMPLETED
A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Essential Hypertension
Eligibility:
MALE
20-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.
Eligibility Criteria
Inclusion
- age: 20 - 40 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00991783
Start Date
August 1 2009
End Date
November 1 2009
Last Update
November 4 2009
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