The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca
Phase 1
Completed
- Conditions
- Healthy Male Volunteers
- Interventions
- Drug: Livasupril Cap.160/2mgDrug: Lipilfen cap. 160mgDrug: Livaro tab. 2mg
- Registration Number
- NCT02250976
- Lead Sponsor
- Hanlim Pharm. Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 41
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Livasupril Cap.160/2mg Livasupril Cap.160/2mg * Fenofibrate pellet ( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg * once a day Lipilfen cap.160mg, Livaro tab. 2mg Lipilfen cap. 160mg * Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg * Coadministariton of Lipilfen cap.160mg and Livaro tab. 2mg, once a day Lipilfen cap.160mg, Livaro tab. 2mg Livaro tab. 2mg * Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg * Coadministariton of Lipilfen cap.160mg and Livaro tab. 2mg, once a day
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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) 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) 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) 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) 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) 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
Trial Locations
- Locations (1)
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of