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.

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