A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01509196
First received: January 10, 2012
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: HIP0901 / Lipidilsupra
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • AUC of Fenofibric acid [ Time Frame: 0-96 hrs ] [ Designated as safety issue: No ]
  • Cmax of Fenofibric acid [ Time Frame: 0-96 hrs ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509196

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01509196     History of Changes
Other Study ID Numbers: HM-FEN-101
Study First Received: January 10, 2012
Last Updated: March 28, 2012
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Fenofibric acid
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014