A Randomized, Open Label, Cross-over Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUCtau
研究概览
简要总结
This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Glucodown(Metformin SR). Also investigate drug interaction between separate and combination administration.
Total number of subjects is 36. 6 group(6 for 1 group), 3 period, consecutive 5 day administration, 10 days washout after 5th day of administration.
All subjects take Crestor alone, Glucodown alone, Crestor+Glucodown combination during 3 each period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20~50 yrs old, healthy Korean Subjects
- •Body weight <ideal body weight±20%
- •No congenital, chronic disease, No current disease
- •Subjects who are diagnosed to include by medical doctor from laboratory and ECG result.
- •Subjects who agree to keep contraceptive methods during the clinical trial.
排除标准
- •Subjects who are allergic to investigational drug.
- •Subjects who have a medical history which can affect the clinical trial.
- •Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
- •Subjects who have taken other medicine in recent 2~4 weeks.
- •Subjects who have a risk of hypoglycemia and imbalance in taking a diet.
研究组 & 干预措施
1
This arm is consist of 6 subject. Crestor 10mg and Glucodown 750mg for 5 day during period 1. Crestor 10mg alone for 5 day during period 2. Glucodown 750mg alone for 5 day during period 3.
干预措施: Crestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg) (Drug)
2
This arm is consist of 6 subject. Glucodown 750mg alone for 5 day during period 1. Crestor 10mg and Glucodown 750mg for 5 day during period 2. Crestor 10mg alone for 5 day during period 3.
干预措施: Crestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg) (Drug)
3
This arm is consist of 6 subject. Crestor 10mg alone for 5 day during period 1. Glucodown 750mg alone for 5 day during period 2. Crestor 10mg and Glucodown 750mg for 5 day during period 3.
干预措施: Crestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg) (Drug)
4
This arm is consist of 6 subject. Glucodown 750mg alone for 5 day during period 1. Crestor 10mg alone for 5 day during period 2. Crestor 10mg and Glucodown 750mg for 5 day during period 3.
干预措施: Crestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg) (Drug)
5
This arm is consist of 6 subject. Crestor 10mg alone for 5 day during period 1. Crestor 10mg and Glucodown 750mg for 5 day during period 2. Glucodown 750mg alone for 5 day during period 3.
干预措施: Crestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg) (Drug)
6
This arm is consist of 6 subject. Crestor 10mg and Glucodown 750mg for 5 day during period 1. Glucodown 750mg alone for 5 day during period 2. Crestor 10mg alone for 5 day during period 3.
干预措施: Crestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg) (Drug)
结局指标
主要结局
AUCtau
时间窗: 72 hr
Css,max
时间窗: 72 hr
次要结局
- AUCss,last(72 hr)
- AUCss,inf(72 hr)
- Css,min(72 hr)
- Tss,max(72 hr)
- t1/2(72 hr)