Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin
Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin
To evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic
 characteristics of each arms after repeated administrating Lipilfen cap. 160mg and Livalo
 tab. 2mg through 3 period by separately or combinedly.
To develop combination product of micronized fenofibrate plus pitavastatin, we would like to
 evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic
 characteristics of each arms after repeated administrating Lipilfen cap. 160mg(micronized
 fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong Wae
 Pharm. through 3 period by separately or combinedly.
Inclusion Criteria:

 1. Years 20-55

 2. Body weight≥50kg and 18≤BMI≤29kg/m2

 3. Volunteer

 Exclusion Criteria:

 1. Subject with serious active cardiovascular, respiratory, hepatology, renal,
 hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological
 disease or history of such disease

 2. Subject with symptoms of acute disease within 28days prior to study medication dosing

 3. Subject with known for history which affect on the absorption, distribution,
 metabolism or excretion of drug

 4. Subject with clinically significant active chronic disease

 5. 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

 6. Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus
 antibody, venereal disease research laboratory test

 7. Use of any prescription medication within 14 days prior to study medication dosing

 8. Use of any medication such as over-the-counter medication including oriental
 medication within 7 days prior to study medication dosing

 9. Subject with clinically significant allergic disease (except for mild allergic
 rhinitis and mild allergic dermatitis that are not needed to administer drug)

 10. Subject with known for hypersensitivity reaction to fenofibrate, fenofibric acid or
 statin

 11. gallbladder disease

 12. Subject who experiences photo-allergy or photo-toxicity during administrating fibrates
 or ketoprofen

 13. Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency
 or glucose-galactose malabsorption

 14. Subject who is not albe to taking the institutional standard meal

 15. Subject with whole blood donation within 60days, component blood donation within
 20days

 16. Subjects receiving blood transfusion within 30days prior to study medication dosing

 17. Participation in any clinical investigation within 60days prior to study medication
 dosing

 18. Continued excessive use of caffeine (caffeine > five cups/day),
 alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day)

 19. 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