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

Study Overview
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Brief Summary
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To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: CJ-30039
* Drug: fenofibric acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ-30039<br>Incrementally Modified Drugs of fenofibric acid | Drug: CJ-30039<br>* single dose<br>* Other names: Incrementally Modified Drugs of fenofibric acid;|
| Active Comparator: fenofibric acid<br>Greencross Lipidil Supra 160mg | Drug: fenofibric acid<br>* single dose<br>* Other names: Greencross Lipidil Supra 160mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of fenofibric acid |  | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of fenofibric acid |  | up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Pharmacokinetics