To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Fenofibrate; Fenofibric acid

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