Status:
COMPLETED
A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912
Eligibility Criteria
Inclusion
- Age between 20 and 45
- Signed informed consent form
- weight : over 45kg and in the range of ±20% of IBW
Exclusion
- Has a medical history of hypersensitivity to atorvastatin or irbesartan
- severe Hypotension
- Not eligible for subject in health examination within 28 days of IP administration
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01447797
Start Date
September 1 2011
End Date
December 1 2011
Last Update
April 3 2012
Active Locations (1)
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1
Korea University Anam Hospital
Seoul, South Korea