Randomized, Open Label, Multiple-Dose, 6-sequence, 3-period, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium in Healthy Male Subjects
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
- Metformin, Rosuvastatin Cmaxss
研究概览
简要总结
We investigate the potential pharmacokinetic drug-drug interaction between metformin extended release and rosuvastatin in healthy male volunteers who receive metformin extended release alone, rosuvastatin alone, and both together in a 3 period repeatedly.
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
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, age 20 to 55 years.
- •The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
- •Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- •Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
- •Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.
- •Systolic blood pressure <90mmHg or Diastolic blood pressure < 60 mmHg, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure) during the screening procedure.
研究组 & 干预措施
Crestor tablet 20 mg
Crestor tablet 20 mg single--->wash out---->Glucophage SR tablet 750 mg single---->washout--->Glucophage SR tablet 750 mg, Crestor tablet 20 mg both
干预措施: Glucophage SR tablet 750 mg, Crestor tablet 20 mg (Drug)
Glucophage SR tablet 750 mg and Crestor tablet 20 mg both
Glucophage SR tablet 750 mg, Crestor tablet 20 mg both--->wash out---->Glucophage SR tablet 750 mg single------>washout--->Crestor tablet 20 mg single
干预措施: Glucophage SR tablet 750 mg, Crestor tablet 20 mg (Drug)
Glucophage SR tablet 750 mg
Glucophage SR tablet 750 mg single --->wash out---->Crestor tablet 20 mg single---->washout--->Glucophage SR tablet 750 mg, Crestor tablet 20 mg both
干预措施: Glucophage SR tablet 750 mg, Crestor tablet 20 mg (Drug)
结局指标
主要结局
Metformin, Rosuvastatin Cmaxss
时间窗: 0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)
metformin, rosuvastatin AUC
时间窗: 0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)
次要结局
- Metformin, Rosuvastatin t1/2(0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16))
- Metformin, Rosuvastatin C min,ss(0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16))
- Metformin, Rosuvastatin Vd/Fss(0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16))
- Metformin, Rosuvastatin tmaxss(0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16))
- Metformin, Rosuvastatin CL/Fss(0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16))