Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin

NCT ID: NCT01767610

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-07-31

Brief Summary

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.

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.

Conditions

Healthy Male Volunteers

Study Design

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

Study Groups

micronized fenofibrate

Group Type: EXPERIMENTAL

micronized fenofibrate 160mg

Intervention Type: DRUG

pitavastatin Ca

Group Type: EXPERIMENTAL

pitavastatin Ca 2mg

Intervention Type: DRUG

micronized fenofibrate plus pitavastatin Ca

Group Type: EXPERIMENTAL

micronized fenofibrate 160mg plus pitavastatin Ca 2mg

Intervention Type: DRUG

Interventions

micronized fenofibrate 160mg

Intervention Type: DRUG

pitavastatin Ca 2mg

Intervention Type: DRUG

micronized fenofibrate 160mg plus pitavastatin Ca 2mg

Intervention Type: DRUG

Other Intervention Names

Lipilfen cap. 160mg : once daily for 5 days; Livalo tab. 2mg : once daily for 5 days; Lipilfen cap. 160mg plus Livalo tab. 2mg : once daily for 5 days

Eligibility Criteria

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

• Minimum Eligible Age: 20 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

Locations

Kyungpook National University Hospital

Daegu, , South Korea

Countries

South Korea

Other Identifiers

HL-PIF-101

Identifier Type: -

Identifier Source: org_study_id