Status:
COMPLETED
A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Essential Hypertension
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.
Eligibility Criteria
Inclusion
- age: 20 - 45 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
Exclusion
- known allergy to Fimasartan, ketoconazole and rifampicin
- 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 :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00938262
Start Date
April 1 2009
End Date
August 1 2009
Last Update
October 8 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.