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 HealthCare Corporation
ClinicalTrials.gov Identifier:
NCT01501435
First received: December 24, 2011
Last updated: August 1, 2012
Last verified: December 2011
  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:


Further study details as provided by CJ HealthCare 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
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 yonsei university severance hospital
  More Information

No publications provided

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: August 1, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CJ HealthCare 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 July 24, 2014