This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
December 24, 2011
December 29, 2016
December 2011
April 2012   (Final data collection date for primary outcome measure)
Peak Plasma Concentration (Cmax) of fenofibric acid [ Time Frame: up to 48 hours ]
Not Provided
Complete list of historical versions of study NCT01501435 on ClinicalTrials.gov Archive Site
Area under the plasma concentration versus time curve (AUC) of fenofibric acid [ Time Frame: up to 48 hours ]
Not Provided
Not Provided
Not Provided
 
To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra
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
To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra

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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: CJ-30039
    single dose
    Other Name: Incrementally Modified Drugs of fenofibric acid
  • Drug: fenofibric acid
    single dose
    Other Name: Greencross Lipidil Supra 160mg
  • Experimental: CJ-30039
    Incrementally Modified Drugs of fenofibric acid
    Intervention: Drug: CJ-30039
  • Active Comparator: fenofibric acid
    Greencross Lipidil Supra 160mg
    Intervention: Drug: fenofibric acid
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
Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01501435
CJ_FEN_101
No
Not Provided
No
Not Provided
CJ HealthCare Corporation
CJ HealthCare Corporation
Not Provided
Principal Investigator: Min-su Park, MD PhD Severance Hospital
CJ HealthCare Corporation
December 2016

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