The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca

Study Overview
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Brief Summary
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To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.

Detailed Description
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To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.

Official Title
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A Clinical Trial to Evaluate the Pharmacokinetics of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca Under Fed Condition in Healthy Male Volunteers

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: Livasupril Cap.160/2mg
* Drug: Lipilfen cap. 160mg
* Drug: Livaro tab. 2mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects age 19 to 55 at the screening visit Body weight≥50kg and within Ideal body weight±20% Subject who is judged to be eligible according to clinical laboratory tests including hematological examination, blood chemistry examination, urine analysis Subject who volunteerly determined to participate in and agreed to comply with precautions after totally understand the detailed explanations about this study Exclusion Criteria: Subject with serious active cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease Subject with symptoms of acute disease within 28days prior to study medication dosing Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug Subject with clinically significant active chronic disease Subject with any of the following conditions in laboratory test i. AST(aspartate aminotransferase) or ALT(alanine transferase) > upper normal limit × 1.5 ii. Total bilirubin > upper normal limit × 1.5 iii. renal failure with Creatinine clearance < 50mL/min iv. creatine phosphokinase > upper normal limit × 2 Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, human immunodeficiency virus antigen/antibody,venereal disease research laboratory test Use of any prescription medication within 14 days prior to study medication dosing Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug) Subject with known for hypersensitivity reaction to fenofibrate, fenofibric acid or statin gallbladder disease Subject who experiences photo-allergy or photo-toxicity during administrating fibrates or ketoprofen Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption Subject who is not able to taking the institutional standard meal Subject with whole blood donation within 60days, component blood donation within 20days Subjects receiving blood transfusion within 30days prior to study medication dosing Participation in any clinical investigation within 60days prior to study medication dosing Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day) Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator

Ages Eligible for Study
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Minimum Age: 19 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Livasupril Cap.160/2mg<br>Fenofibrate pellet ( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg once a day | Drug: Livasupril Cap.160/2mg<br>* Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg<br>|
| Active Comparator: Lipilfen cap.160mg, Livaro tab. 2mg<br>Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg Coadministariton of Lipilfen cap.160mg and Livaro tab. 2mg, once a day | Drug: Lipilfen cap. 160mg<br>* Micronized fenofibrate 160mg<br>Drug: Livaro tab. 2mg<br>* Pitavastatin Ca 2mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast(area under the curve) of fenofibric acid |  | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | 
| Cmax(maximum concentration) of fenofibric acid |  | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | 
| AUClast(area under the curve) of pitavastatin |  | Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | 
| Cmax(maximum concentration) of pitavastatin |  | Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf(area under the curve) of fenofibric acid |  | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | 
| Tmax(time to Maximum Plasma Concentration) of fenofibric acid |  | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | 
| t1/2(half life) of fenofibric acid |  | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) | 
| AUCinf(area under the curve) of pitavastatin |  | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | 
| Tmax(time to Maximum Plasma Concentration) of pitavastatin |  | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | 
| t1/2(half life) of pitavastatin |  | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) | 
| Number of participants with adverse events |  | Participants will be followed for the duration of hospital stay, and expected period for maximum 7 days from the discharge |