NCT02250976已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- AUClast(area under the curve) of pitavastatin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Livasupril Cap.160/2mg
Experimental
- Fenofibrate pellet ( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
- once a day
干预措施: Livasupril Cap.160/2mg (Drug)
Lipilfen cap.160mg, Livaro tab. 2mg
Active Comparator
- Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg
- Coadministariton of Lipilfen cap.160mg and Livaro tab. 2mg, once a day
干预措施: Lipilfen cap. 160mg (Drug)
Lipilfen cap.160mg, Livaro tab. 2mg
Active Comparator
- Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg
- Coadministariton of Lipilfen cap.160mg and Livaro tab. 2mg, once a day
干预措施: Livaro tab. 2mg (Drug)
结局指标
主要结局
AUClast(area under the curve) of pitavastatin
时间窗: 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 fenofibric acid
时间窗: 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 fenofibric acid
时间窗: 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 pitavastatin
时间窗: 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)
次要结局
- 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)
研究者
研究点 (1)
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