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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation
ClinicalTrials.gov Identifier:
NCT01501435
First received: December 24, 2011
Last updated: December 29, 2016
Last verified: December 2016
  Purpose
To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra

Condition Intervention Phase
Healthy
Drug: CJ-30039
Drug: fenofibric acid
Phase 1

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

Resource links provided by NLM:


Further study details as provided by CJ HealthCare Corporation:

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

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

Enrollment: 48
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 24, 2011
Last Updated: December 29, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by CJ HealthCare Corporation:
Safety
Pharmacokinetics

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

ClinicalTrials.gov processed this record on March 24, 2017