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Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of HIP0901 Capsule

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ClinicalTrials.gov Identifier: NCT01555398
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : April 8, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the effect of food on the pharmacokinetic characteristics of fenofibric acid for HIP0901 capsule.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Randomized Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Fenofibric Acid for HIP0901 Capsule in Healthy Male Subjects
Study Start Date : February 2012
Primary Completion Date : March 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Fasting conditions
Investigational product administrated under fasting condition.
Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions
The study drug(HIP0901 capsule(Fenofibric acid, 135mg)) will be administrated under fed or fasting conditions
Active Comparator: Fed conditions
Investigational product administrated 30min after starting a high-fat breakfast.
Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions
The study drug(HIP0901 capsule(Fenofibric acid, 135mg)) will be administrated under fed or fasting conditions


Outcome Measures

Primary Outcome Measures :
  1. AUC of Fenofibric acid [ Time Frame: 0-96 hrs ]
  2. Cmax of Fenofibric acid [ Time Frame: 0-96 hrs ]

Eligibility Criteria

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): NCT01555398


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: NCT01555398     History of Changes
Other Study ID Numbers: HM-FEN-102
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Hanmi Pharmaceutical Company Limited:
Fenofibric acid
HIP0901
food effect

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