Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin

Open-label, Randomized, Repeated Dosing Crossover Study to Evaluate the Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin in Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: micronized fenofibrate 160mg; Drug: pitavastatin Ca 2mg; Drug: micronized fenofibrate 160mg plus pitavastatin Ca 2mg

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: micronized fenofibrate	Drug: micronized fenofibrate 160mg; Other Names: Lipilfen cap. 160mg : once daily for 5 days
Experimental: pitavastatin Ca	Drug: pitavastatin Ca 2mg; Other Names: Livalo tab. 2mg : once daily for 5 days
Experimental: micronized fenofibrate plus pitavastatin Ca	Drug: micronized fenofibrate 160mg plus pitavastatin Ca 2mg; Other Names: Lipilfen cap. 160mg plus Livalo tab. 2mg : once daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Drug-Drug interaction evaluation (Cmax,ss, Cmin,ss, Tmax,ss)	just before dosing on 1st day and 4th day of each period and 0, 0.25, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48hr on final 5th dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	Participants will be followed for the duration of study medication dosing days and hospital stay, and expected average of 3days and follow-up period for maximum 7 days from the discharge

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 11, 2013
• First Posted (Estimate): January 14, 2013

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Gastrointestinal Agents; Dermatologic Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Infliximab; Fenofibrate; Pitavastatin
• Other Study ID Numbers: HL-PIF-101