Status:
COMPLETED
Safety and Pharmacokinetic Comparison of Co-administration and a Combination Drug of Rosuvastatin and Olmesartan in Healthy Male Volunteers
Lead Sponsor:
Severance Hospital
Conditions:
Healthy
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and Olmesartan (re...
Eligibility Criteria
Inclusion
- Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease
Exclusion
- History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
- Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
- Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
- Use of any substance that could induce or inhibit drug metabolism enzymes
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01823900
Start Date
January 1 2012
End Date
March 1 2012
Last Update
April 11 2013
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea, 120-752