None listed
Conditions
Interventions
Drug : Single-dose in fed condition, crossover study, washout period : 7 days
Group1, Period 1 and Group2, Period 2 : Lipilfen Cap.160mg(micronized fenofibrate, 160mg) 1 cap. and Livaro tab.2mg(pitava
Sponsors
Hanlim Pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy male subjects age 19 to 55 at the screening visit 2) Body weight=50kg and within Ideal body weight±20% 3) Subject who is judged to be eligible according to clinical laboratory tests including hematological examination, blood chemistry examination, urine analysis and 4) Subject who volunteerly determined to participate in and agreed to comply with precautions after totally understand the detailed explanations about this study
Exclusion criteria
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 laboratoy test i. AST(aspartate aminotransferase)or ALT(alanine transferase) > upper normal limit X 1.5 ii. Total bilirubin > upper normal limit X 1.5 iii. Renal failure with creatinine clearance upper normal limit X 2 6) Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, human immunodeficiency virus antigen/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-cunter 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 and statin 11) Gallbladder disease 12) Subject aho experiences photo-allergy or photo-toxicity during administrating fibrates and ketoprofen 13) Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption 14) Subject who is not able 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/day) 19) Subjects with decision of nonparticipation through inverstigator'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 |
|---|---|
| AUClase, Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCint, Tmax, t1/2;Number of participants with adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactHyun-Woo Jun
Kyungpook National University Hospital
Outcome results
None listed