NCT01925300撤回1 期
A Randomized, Open-label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Bisoprolol and Rosuvastatin in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Assessment of the drug-drug interactions of bisoprolol 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 bisoprolol and rosuvastatin 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
- Basic Science
- 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(inclusive)
- •Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
- •Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 150 mmHg, 60 mmHg ≤ diastolic blood pressure ≤ 100 mmHg, 50 beats per minute ≤ pulse rate ≤ 100 beats per minute)
- •Available for the entire study period
- •Understand the requirements of the study and voluntarily consent to participate in the study
排除标准
- •Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
- •History of clinically significant arrhythmic, peripheral vascular,thyroid, bronchospasm, asthma disease
- •Subjects with anaphylaxis to bisoprolol and/or rosuvastatin
- •History of drug abuse
- •History of caffeine, alcohol, smoking abuse
- •caffeine(coffee,tea,coke) or grapefruit juice > 4cups/day
- •smoking > 20 cigarettes/day
- •alcohol > 140g/week
- •Clinical laboratory test values are outside the accepted normal range
- •AST(Aspartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range
- •CK(Creatine Kinase) > 1.5 times to normal range
- •Estimated GFR(Glomerular Filtration Rate) < 60 mL/min
- •Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing
- •Subjects considered as unsuitable based on medical judgement by investigators
研究组 & 干预措施
Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, qd
Experimental
Single administration : 6 days, per oral
干预措施: Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab (Drug)
Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab, qd
Experimental
Single administration : 6 days, per oral
干预措施: Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab (Drug)
Concor 5mg 2T and Crestor 20 mg 1Tab, qd
Experimental
Combination administration : 6 days, per oral
干预措施: Concor 5mg 2T and Crestor 20 mg 1Tab (Drug)
结局指标
主要结局
Assessment of the drug-drug interactions of bisoprolol and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve)
时间窗: 6 days
Administration of Investigational Product : 6 days/period(total 3 period)
次要结局
- Assessment of the bisoprolol and rosuvastatin:tmax,ss(Time to reach Cmax,ss), t1/2, Cmin,ss(Minimum steady-state plasma drug concentration during a dosage interval ), CL/Fss(Oral Clearance), Vd/Fss(Apparent Volume of Distribution)(6 days)
研究者
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