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

NCT ID: NCT02250976

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2014-10-31

Brief 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.

Detailed Description

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.

Conditions

Healthy Male Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Livasupril Cap.160/2mg

• Fenofibrate pellet ( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
• once a day

Group Type: EXPERIMENTAL

Livasupril Cap.160/2mg

Intervention Type: DRUG

Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg

Lipilfen cap.160mg, Livaro tab. 2mg

• Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg
• Coadministariton of Lipilfen cap.160mg and Livaro tab. 2mg, once a day

Group Type: ACTIVE_COMPARATOR

Lipilfen cap. 160mg

Intervention Type: DRUG

Micronized fenofibrate 160mg

Livaro tab. 2mg

Intervention Type: DRUG

Pitavastatin Ca 2mg

Interventions

Livasupril Cap.160/2mg

Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg

Intervention Type: DRUG

Lipilfen cap. 160mg

Micronized fenofibrate 160mg

Intervention Type: DRUG

Livaro tab. 2mg

Pitavastatin Ca 2mg

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young-Ran Yoon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

Kyungpook National University Hospital

Daegu, , South Korea

Countries

South Korea

Other Identifiers

HL-PIF-103

Identifier Type: -

Identifier Source: org_study_id