A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Essential Hypertension
- Registration Number
- NCT00991783
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method AUC, Cmax, Tmax, CL 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24 hours at 7 day and 28 day
- Secondary Outcome Measures
Name Time Method