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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Fenofibrate; Pitavastatin

Criteria

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