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

December 24, 2011
August 1, 2012
December 2011
April 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01501435 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: CJ-30039
    single dose
  • Drug: Active Comparator: Greencross Lipidil Supra 160mg
    single dose
  • Experimental: CJ-30039
    Intervention: Drug: CJ-30039
  • Active Comparator: Greencross Lipidil Supra 160mg
    Intervention: Drug: Active Comparator: Greencross Lipidil Supra 160mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
June 2012
April 2012   (final data collection date for primary outcome measure)

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
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01501435
CJ_FEN_101
No
CJ HealthCare Corporation
CJ HealthCare Corporation
Not Provided
Principal Investigator: Min-su Park, MD PhD yonsei university severance hospital
CJ HealthCare Corporation
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP