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