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A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509196
First Posted: January 12, 2012
Last Update Posted: March 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
  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
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

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 ]
  • Cmax of Fenofibric acid [ Time Frame: 0-96 hrs ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01509196     History of Changes
Other Study ID Numbers: HM-FEN-101
First Submitted: January 10, 2012
First Posted: January 12, 2012
Last Update Posted: March 29, 2012
Last Verified: March 2012

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
Lipid Regulating Agents