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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
History of Changes
  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:

U.S. FDA Resources

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 May 23, 2013