A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HIP0901 capsules and Lipidilsupra tablets.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Fenofibrate; Fenofibric acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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