A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01509196
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HIP0901 / Lipidilsupra	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-label, Randomized Comparative Study to Evaluate the Pharmacokinetic Characteristics of Fenofibric Acid Between Lipidilsupra Tablet and HIP0901 Capsule in Healthy Male Subjects
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HIP0901 Fenofibric acid	Drug: HIP0901 / Lipidilsupra; HIP0901 capsule(Fenofibric acid, 135mg) / Lipidilsupra tablet(Fenofibrate, 160mg)
Active Comparator: Lipidilsupra Fenofibrate	Drug: HIP0901 / Lipidilsupra; HIP0901 capsule(Fenofibric acid, 135mg) / Lipidilsupra tablet(Fenofibrate, 160mg)

Outcome Measures

Primary Outcome Measures

1. AUC of Fenofibric acid [0-96 hrs]

2. Cmax of Fenofibric acid [0-96 hrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Anam Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

• Principal Investigator: Ji-Young Park, MD, PhD, Korea University Anam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT01509196
• Other Study ID Numbers: HM-FEN-101
• First Posted: Jan 12, 2012
• Last Update Posted: Mar 29, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Hanmi Pharmaceutical Company Limited: Fenofibric acid; HIP0901; Lipidilsupra

Study Results

No Results Posted as of Mar 29, 2012