NCT02060019已完成1 期
A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
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
- 57
- 试验地点
- 1
- 主要终点
- Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve)
研究概览
简要总结
This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Male volunteers in the age between 20 and 55 years old
- •The weight range is not exceed ±20% of ideal weight Ideal weight = [height -100]*0.9
- •Subjects with no history of any significant chronic disease
- •Judged to be in good health on the basis of their electrocardiography (ECG) and routine laboratory data obtained within 3 weeks prior to study drug administration
- •Willing to adhere to protocol requirements and sign a informed consent form
排除标准
- •History of clinically significant allergies including drug allergies
- •History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
- •History of genetic muscular disease and family history
- •hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100)
- •AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( > 1.5 times to normal range
- •Creatinine clearance < 80mL/min
- •Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
- •Serious injury, surgery and acute illness within 4 weeks prior to drug administration
- •History of alcohol, smoking abuse
- •alcohol > 21 units/week, 1 unit=10g=12.5mL of pure alcohol
- •smoking > 10 cigarettes/day
- •Use of any other medication, including herbal products, within the 2 weeks before dosing
- •Participated in a previous clinical trial within 3 months prior to drug administration
- •Subjects with whole blood donation within 2 months, component blood donation within months 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
- •Clinical laboratory test values are positive (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
- •Subjects considered as unsuitable based on medical judgement by investigators
研究组 & 干预措施
exforge 10/160mg(amlodipine 10mg, valsartan160mg)
Experimental
1 tablet daily for 10days
干预措施: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg. (Drug)
crestor 20mg(rosuvastatin 20mg)
Experimental
1 tablet daily for 7days
干预措施: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg. (Drug)
结局指标
主要结局
Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve)
时间窗: 3 days
after steady state (Administration of Investigational Product 7day or 10days)
次要结局
- Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2(3 days)
研究者
研究点 (1)
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