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Compare Safety and Pharmacokinetic(PK) Properties of CJ-30039 and Lipidil Supra and To Investigate Food-effect on PK of CJ-30039 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier:
NCT01501435
First received: December 24, 2011
Last updated: August 1, 2012
Last verified: December 2011
History of Changes
  Purpose

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.

Condition Intervention Phase
Healthy
 Drug: CJ-30039
Drug: Active Comparator: Greencross Lipidil Supra 160mg
 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: A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra and To Investigate Food-effect on Pharmacokinetics of CJ-30039 in Healthy Male Volunteers

Resource links provided by NLM:

Drug Information available for: Fenofibrate
U.S. FDA Resources

Further study details as provided by CJ Cheiljedang Corporation:

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 Drug: CJ-30039
single dose
Active Comparator: Greencross Lipidil Supra 160mg Drug: Active Comparator: Greencross Lipidil Supra 160mg
single dose

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
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 Cheiljedang Corporation
Investigators
Principal Investigator: Min-su Park, MD PhD yonsei university severance hospital
  More Information

No publications provided

Responsible Party: CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier: NCT01501435     History of Changes
Other Study ID Numbers: CJ_FEN_101
Study First Received: December 24, 2011
Last Updated: August 1, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CJ Cheiljedang Corporation:
Safety
Pharmacokinetics

Additional relevant MeSH terms:
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013