A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HIP0901 / Lipidilsupra

• Registration Number: NCT01509196
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2011-12
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-12
• Study Completion: 2012-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HIP0901	HIP0901 / Lipidilsupra	Fenofibric acid
Lipidilsupra	HIP0901 / Lipidilsupra	Fenofibrate

Primary Outcome Measures

Name	Time	Method
Cmax of Fenofibric acid	0-96 hrs
AUC of Fenofibric acid	0-96 hrs

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of