A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers
A Clinical Trial to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers
1 other identifier
interventional
14
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2009
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 7, 2009
CompletedFirst Posted
Study publicly available on registry
October 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedNovember 4, 2009
November 1, 2009
3 months
October 7, 2009
November 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Digoxin (7 days), Digoxin + Fimasartan (7 days)
Eligibility Criteria
You may qualify if:
- age: 20 - 40 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kyung-Sang Yu, MD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2009
First Posted
October 8, 2009
Study Start
August 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
November 4, 2009
Record last verified: 2009-11