Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin

This study is currently recruiting participants.
Verified January 2013 by Hanlim Pharm. Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01767610
First received: January 11, 2013
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Healthy Male Volunteers
Drug: micronized fenofibrate 160mg
Drug: pitavastatin Ca 2mg
Drug: micronized fenofibrate 160mg plus pitavastatin Ca 2mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Open-label, Randomized, Repeated Dosing Crossover Study to Evaluate the Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Hanlim Pharm. Co., Ltd.:

Primary Outcome Measures:
  • Drug-Drug interaction evaluation (Cmax,ss, Cmin,ss, Tmax,ss) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: micronized fenofibrate Drug: micronized fenofibrate 160mg
Other Name: Lipilfen cap. 160mg : once daily for 5 days
Experimental: pitavastatin Ca Drug: pitavastatin Ca 2mg
Other Name: Livaro tab. 2mg : once daily for 5 days
Experimental: micronized fenofibrate plus pitavastatin Ca Drug: micronized fenofibrate 160mg plus pitavastatin Ca 2mg
Other Name: Lipilfen cap. 160mg plus Livaro tab. 2mg : once daily for 5 days

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767610

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

Locations
Korea, Republic of
Kyungpook National University Hospital Recruiting
Dae Gu, Korea, Republic of, 700-721
Contact: Hyun-Woo Jeon, CRC    82 53 420 6944    jjhww@naver.com   
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
  More Information

No publications provided

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01767610     History of Changes
Other Study ID Numbers: HL-PIF-101
Study First Received: January 11, 2013
Last Updated: January 14, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Fenofibrate
Pitavastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014