NCT01501435已完成1 期
A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study to Compare the Pharmacokinetics of CJ-30039 and Lipidil Supra and to Investigate Food-effect on Pharmacokinetics of CJ-30039
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
- 48
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of fenofibric acid
研究概览
简要总结
To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra
详细描述
Study objectives
- To compare the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra after a single oral administration in healthy male volunteers.
- To evaluate the food-effect on pharmacokinetics of CJ-30039 after a single oral administration 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers in the age between 20 and 55 years old
- •BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
- •Subject with no history of any significant chronic disease
排除标准
- •History of clinically significant allergies, including fenofibric acid or Fenofibrate
- •History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
- •History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
- •Clinical laboratory test values are outside the accepted normal range
- •AST(ASpartate Transaminase), ALT(ALanine Transaminase)( > 1.25 times to normal range
- •Total bilirubin > 1.5 times to normal range
- •BUN(Blood Urea Nitrogen) > 25 mg/dL or Creatinine > 1.4 mg/dL
- •CK(Creatine Kinase) > 1.25 times to normal range
- •Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2
- •Clinically significant vital sign
- •SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg
- •DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg
- •History of drug abuse or positive urine screen for drugs
- •History of caffeine, alcohol, smoking abuse
- •caffeine > 5 cups/day
- •alcohol > 201g/week
- •smoking > 10 cigarettes/day
- •Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing
- •Participated in a previous clinical trial within 60 days prior to dosing
- •Donated blood within 60 days prior to dosing
研究组 & 干预措施
CJ-30039
Experimental
Incrementally Modified Drugs of fenofibric acid
干预措施: CJ-30039 (Drug)
fenofibric acid
Active Comparator
Greencross Lipidil Supra 160mg
干预措施: fenofibric acid (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of fenofibric acid
时间窗: up to 48 hours
次要结局
- Area under the plasma concentration versus time curve (AUC) of fenofibric acid(up to 48 hours)
研究者
研究点 (1)
Loading locations...
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