NCT02160743已完成1 期
The Food Effect on Pharmacokinetics and Safety of Fixed-dose Combination of CJ-30056 in Healthy Male Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Peak plasma concentration (Cmax) of atorvastatin
研究概览
简要总结
This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination of "CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)" in healthy male subjects
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
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Willing to adhere to protocol requirements and sign a informed consent form
- •Male volunteers in the age between 20 and 45 years old and have the weight range is not exceed ±20% of ideal weight
- •Subjects with no history of any significant chronic disease
- •Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
排除标准
- •Use of barbital inducer or inhibitor medication within the 4 weeks before dosing
- •Symptom of an acute illness within 4 weeks prior to drug administration
- •History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
- •History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
- •History of clinically significant allergies including drug allergies
- •History of clinically significant allergies about atorvastatin or metformin
- •Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration
- •History of myopathy
- •Clinical laboratory test values are outside the accepted normal range
- •AST or ALT >1.25 times to normal range
- •Total bilirubin >1.5 times to normal range
- •e-GFR <90 mL/min
- •History of drug, caffein(caffein > 5 cups/day), smoking (cigarette > 10/day) or alcohol abuse(alcohol > 30 g/day)or Subjects who have ever drink within 7 days prior to drug administration
- •Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
- •Donated blood within 60 days prior to dosing
- •Participated in a previous clinical trial within 60 days prior to dosing
- •Use of any other medication, including herbal products, within 10 days before dosing
- •Subjects considered as unsuitable based on medical judgement by investigators
结局指标
主要结局
Peak plasma concentration (Cmax) of atorvastatin
时间窗: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
Peak plasma concentration (Cmax) of metformin
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose
area under the plasma concentration versus time curve (AUC0-t) of atorvastatin
时间窗: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
area under the plasma concentration versus time curve (AUC0-t) of metformin
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose
次要结局
- Tmax of Atorvastatin, 2-OH-atorvastatin and metformin(0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose)
- t1/2β of Atorvastatin, 2-OH-atorvastatin and metformin(0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose)
- CL/F of atorvastatin and metformin(0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose)
- Vz/F of atorvastatin and metformin(0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose)
- AUCinf of Atorvastatin, 2-OH-atorvastatin and metformin(0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose)
- Peak plasma concentration (Cmax) of 2-OH-atorvastatin(0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose)
- area under the plasma concentration versus time curve (AUC0-t) of 2-OH-atorvastatin(0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose)
研究者
研究点 (2)
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