Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of Atorvastatin
研究概览
简要总结
This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin and metformin XR, in healthy 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
- 19 Years 至 55 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 19 and 55 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
研究组 & 干预措施
Group 1
Single-dose crossover
- Reference: Atorvastatin 20mg and Metformin XR 500mg
- Test: CJ-30056 20/500mg
Once daily Oral administration with 7days of washout period
干预措施: Atorvastatin 20mg and Metformin XR 500mg (Reference) (Drug)
Group 1
Single-dose crossover
- Reference: Atorvastatin 20mg and Metformin XR 500mg
- Test: CJ-30056 20/500mg
Once daily Oral administration with 7days of washout period
干预措施: CJ-30056 20/500mg (Test) (Drug)
Group 2
Single-dose crossover
- Test: CJ-30056 20/500mg
- Reference: Atorvastatin 20mg and Metformin XR 500mg
Once daily Oral administration with 7days of washout period
干预措施: Atorvastatin 20mg and Metformin XR 500mg (Reference) (Drug)
Group 2
Single-dose crossover
- Test: CJ-30056 20/500mg
- Reference: Atorvastatin 20mg and Metformin XR 500mg
Once daily Oral administration with 7days of washout period
干预措施: CJ-30056 20/500mg (Test) (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of Atorvastatin
时间窗: Upto 36 hours
Maximum plasma concentration (Cmax) of Metformin
时间窗: Upto 24 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin
时间窗: Upto 36 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Metformin
时间窗: Upto 24 hours
次要结局
- Maximum plasma concentration (Cmax) of 2-OH-atorvastatin(Upto 36 hours)
- Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin(Upto 36 hours)
- CL/F of Atorvastatin and Metformin(Upto 36 hours)
- Vd/F of Atorvastatin and Metformin(Upto 36 hours)