Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin

Hanlim Pharm

Status and phase

Completed

Phase 1

Conditions

Healthy Male Volunteers

Treatments

Drug: micronized fenofibrate 160mg plus pitavastatin Ca 2mg

Drug: pitavastatin Ca 2mg

Drug: micronized fenofibrate 160mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01767610

HL-PIF-101

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Years 20-55
Body weight≥50kg and 18≤BMI≤29kg/m2
Volunteer

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, 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 albe 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