An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Following Coadministration of Metformin and Rosuvastatin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax,ss, AUCτ
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.
详细描述
Drug-drug Interaction Following Co-administration of Metformin 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
- 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
- •19~55 years healthy male
- •BMI measurement 19.0kg/m^2~ 28.0kg/m^2
- •Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
排除标准
- •History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
- •SBP>140mmHg or <90mmHg, DBP>90mmHg or <60mmHg.
- •An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- •History of drug abuse
- •A alcohol consumer(alcohol>140g/week) or smoker(cigarette>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics)
- •Administrated investigational product in a previous clinical trial within 60 days of the screening day in this study.
- •Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin)
- •Glomerular filtration rate<60mL/min
- •Donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .
研究组 & 干预措施
Rosuvastatin
Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin
干预措施: Rosuvastatin (Drug)
Metformin
Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration
干预措施: Metformin (Drug)
Metformin
Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration
干预措施: Rosuvastatin (Drug)
Metformin
Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration
干预措施: Metformin and Rosuvastatin (Drug)
Rosuvastatin
Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin
干预措施: Metformin (Drug)
Rosuvastatin
Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin
干预措施: Metformin and Rosuvastatin (Drug)
Co-administration
Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin
干预措施: Metformin (Drug)
Co-administration
Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin
干预措施: Rosuvastatin (Drug)
Co-administration
Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin
干预措施: Metformin and Rosuvastatin (Drug)
结局指标
主要结局
Cmax,ss, AUCτ
时间窗: 32h
次要结局
- Vd/Fss(32h)
- CL/Fss(32h)
- Tmax,ss(32h)
- t1/2(32h)
- Cmin,ss(32h)