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Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin

Information source: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Male Volunteers

Intervention: micronized fenofibrate 160mg (Drug); pitavastatin Ca 2mg (Drug); micronized fenofibrate 160mg plus pitavastatin Ca 2mg (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Hanlim Pharm. Co., Ltd.

Overall contact:
Young-Ran Woon, M.D., Ph.D., Asso. Prof., Phone: 82 53 420 4950, Email: yry@knu.ac.kr


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Drug-Drug interaction evaluation (Cmax,ss, Cmin,ss, Tmax,ss)

Secondary outcome: Number of participants with adverse events


Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Male.


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

Locations and Contacts

Young-Ran Woon, M.D., Ph.D., Asso. Prof., Phone: 82 53 420 4950, Email: yry@knu.ac.kr

Kyungpook National University Hospital, Dae Gu 700-721, Korea, Republic of; Recruiting
Hyun-Woo Jeon, CRC, Phone: 82 53 420 6944, Email: jjhww@naver.com
Additional Information

Starting date: January 2013
Last updated: January 14, 2013

Page last updated: August 23, 2015

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