Clinical trial NCT02250976: The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca
Official title: A Clinical Trial to Evaluate the Pharmacokinetics of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca Under Fed Condition in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 41
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: AUClast(area under the curve) of fenofibric acid
timeFrame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)
measure: Cmax(maximum concentration) of fenofibric acid
timeFrame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)
measure: AUClast(area under the curve) of pitavastatin
timeFrame: 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)
measure: Cmax(maximum concentration) of pitavastatin
timeFrame: 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 outcomes:
measure: AUCinf(area under the curve) of fenofibric acid
timeFrame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)
measure: Tmax(time to Maximum Plasma Concentration) of fenofibric acid
timeFrame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)
measure: t1/2(half life) of fenofibric acid
timeFrame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)
measure: AUCinf(area under the curve) of pitavastatin
timeFrame: 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)
measure: Tmax(time to Maximum Plasma Concentration) of pitavastatin
timeFrame: 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)
measure: t1/2(half life) of pitavastatin
timeFrame: 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)
measure: Number of participants with adverse events
timeFrame: Participants will be followed for the duration of hospital stay, and expected period for maximum 7 days from the discharge
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Young-Ran Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: