KCT0001258进行中（未招募）未知
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
Hanlim Pharmaceutical0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •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
排除标准
- •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 <50mL/min
- •iv. Creatinin phsphokinase > 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
研究者
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