Healthy Male Volunteers
Conditions
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.
Interventions
DRUGpitavastatin Ca 2mg
DRUGmicronized fenofibrate 160mg
DRUGmicronized fenofibrate 160mg plus pitavastatin Ca 2mg
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| 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 |
Countries
South Korea
Outcome results
None listed