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To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra

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.
ClinicalTrials.gov Identifier: NCT01501435
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra

Condition or disease Intervention/treatment Phase
Healthy Drug: CJ-30039 Drug: fenofibric acid Phase 1

Detailed Description:

Study objectives

  • To compare the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra after a single oral administration in healthy male volunteers.
  • To evaluate the food-effect on pharmacokinetics of CJ-30039 after a single oral administration in healthy male volunteers.

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: A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study to Compare the Pharmacokinetics of CJ-30039 and Lipidil Supra and to Investigate Food-effect on Pharmacokinetics of CJ-30039
Study Start Date : December 2011
Primary Completion Date : April 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CJ-30039
Incrementally Modified Drugs of fenofibric acid
Drug: CJ-30039
single dose
Other Name: Incrementally Modified Drugs of fenofibric acid
Active Comparator: fenofibric acid
Greencross Lipidil Supra 160mg
Drug: fenofibric acid
single dose
Other Name: Greencross Lipidil Supra 160mg


Outcome Measures

Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of fenofibric acid [ Time Frame: up to 48 hours ]

Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of fenofibric acid [ Time Frame: up to 48 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male volunteers in the age between 20 and 55 years old
  • BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
  • Subject with no history of any significant chronic disease

Exclusion Criteria:

  • History of clinically significant allergies, including fenofibric acid or Fenofibrate
  • History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
  • History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
  • Clinical laboratory test values are outside the accepted normal range

    • AST(ASpartate Transaminase), ALT(ALanine Transaminase)( > 1.25 times to normal range
    • Total bilirubin > 1.5 times to normal range
    • BUN(Blood Urea Nitrogen) > 25 mg/dL or Creatinine > 1.4 mg/dL
    • CK(Creatine Kinase) > 1.25 times to normal range
  • Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2
  • Clinically significant vital sign

    • SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg
    • DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg
  • History of drug abuse or positive urine screen for drugs
  • History of caffeine, alcohol, smoking abuse

    • caffeine > 5 cups/day
    • alcohol > 201g/week
    • smoking > 10 cigarettes/day
  • Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing
  • Participated in a previous clinical trial within 60 days prior to dosing
  • Donated blood within 60 days prior to dosing
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): NCT01501435


Locations
Korea, Republic of
Yonsei university severance hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
Principal Investigator: Min-su Park, MD PhD Severance Hospital
More Information

Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT01501435     History of Changes
Other Study ID Numbers: CJ_FEN_101
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by CJ HealthCare Corporation:
Safety
Pharmacokinetics

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