Status:
COMPLETED
A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet
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 HIP0901 capsules and Lipidilsupra tablets.
Eligibility Criteria
Inclusion
- Healthy male volunteers, age between 20 and 45
- Informed of the investigational nature of this study and voluntarily agree to participate in this study
- Weight\>50kg, BMI of \>18kg/m2 and \<27kg/m2 subject
Exclusion
- Acute disease within 28 days prior to start of study drug administration
- Use of any prescription medication within 14 days prior to Day 1
- Use of any medication within 7 days prior to Day 1
- Has a severe medical history of hypersensitivity to fibric acid derivative
- Participation in another clinical study within 30 days prior to start of study drug administration
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01509196
Start Date
November 1 2011
End Date
February 1 2012
Last Update
March 29 2012
Active Locations (1)
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1
Korea University Anam Hospital
Seoul, South Korea