NCT01509196

A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

Open-label, Randomized Comparative Study to Evaluate the Pharmacokinetic Characteristics of Fenofibric Acid Between Lipidilsupra Tablet and HIP0901 Capsule in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HIP0901 / Lipidilsupra	HIP0901 capsule(Fenofibric acid, 135mg) / Lipidilsupra tablet(Fenofibrate, 160mg)

Timeline

• Start date: 2011-11-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2012-01-12
• Last updated: 2012-03-29

Locations

1 site across 1 country: South Korea