Healthy Male Volunteers
Conditions
Brief summary
To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.
Detailed description
To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.
Interventions
DRUGLivasupril Cap.160/2mg
Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
DRUGLipilfen cap. 160mg
Micronized fenofibrate 160mg
DRUGLivaro tab. 2mg
Pitavastatin Ca 2mg
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects age 19 to 55 at the screening visit * Body weight≥50kg and within Ideal body weight±20% * Subject who is judged to be eligible according to clinical laboratory tests including hematological examination, blood chemistry examination, urine analysis * Subject who volunteerly determined to participate in and agreed to comply with precautions after totally understand the detailed explanations about this study
Exclusion criteria
* Subject with serious active cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease * Subject with symptoms of acute disease within 28days prior to study medication dosing * Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug * Subject with clinically significant active chronic disease * 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 * Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, human immunodeficiency virus antigen/antibody,venereal disease research laboratory test * Use of any prescription medication within 14 days prior to study medication dosing * Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing * Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug) * Subject with known for hypersensitivity reaction to fenofibrate, fenofibric acid or statin * gallbladder disease * Subject who experiences photo-allergy or photo-toxicity during administrating fibrates or ketoprofen * Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption * Subject who is not able to taking the institutional standard meal * Subject with whole blood donation within 60days, component blood donation within 20days * Subjects receiving blood transfusion within 30days prior to study medication dosing * Participation in any clinical investigation within 60days prior to study medication dosing * Continued excessive use of caffeine (caffeine \> five cups/day), alcohol(alcohol\>30g/day) and severe heavy smoker(cigarette \> 10 cigarettes per day) * 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 |
|---|---|
| AUClast(area under the curve) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) |
| Cmax(maximum concentration) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) |
| AUClast(area under the curve) of pitavastatin | Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) |
| Cmax(maximum concentration) of pitavastatin | Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) |
Secondary
| Measure | Time frame |
|---|---|
| Tmax(time to Maximum Plasma Concentration) of pitavastatin | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) |
| AUCinf(area under the curve) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) |
| Number of participants with adverse events | Participants will be followed for the duration of hospital stay, and expected period for maximum 7 days from the discharge |
| t1/2(half life) of pitavastatin | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) |
| Tmax(time to Maximum Plasma Concentration) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) |
| t1/2(half life) of fenofibric acid | Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points) |
| AUCinf(area under the curve) of pitavastatin | Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points) |
Countries
South Korea
Outcome results
None listed