A Randomized, Open-label, Single-dose, 2-Way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- AUClast of rosuvastatin and metformin
研究概览
简要总结
The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
- •Who has not suffered from clinically significant disease
- •Provision of signed written informed consent
排除标准
- •History of and clinically significant disease
- •A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
- •Administration of other investigational products within 3 months prior to the first dosing.
- •Administration of herbal medicine within 4 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- •Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
研究组 & 干预措施
Group 1 of Study A
single dosing of Rosuvastatin and Metformin 14 days later, single dosing of YH14755
干预措施: Rosuvastatin, Metformin, YH14755 (Drug)
Group 2 of Study A
single dosing of YH14755 14 days later, single dosing of Rosuvastatin and Metformin
干预措施: Rosuvastatin, Metformin, YH14755 (Drug)
Group 1 of Study B
single dosing of YH14755 with fasting state 14 days later, single dosing of YH14755 after having breakfast
干预措施: YH14755 (Drug)
Group 2 of Study B
single dosing of YH14755 after having breakfast 14 days later, single dosing of YH14755 with fasting state
干预措施: YH14755 (Drug)
结局指标
主要结局
AUClast of rosuvastatin and metformin
时间窗: 0~48hr, totally 17 points
Cmax of rosuvastatin and metformin
时间窗: 0~48hr, totally 17 points
次要结局
- t1/2 of rosuvastatin and metformin(0~48hr, totally 17 points)
- %AUC of rosuvastatin and metformin(0~48hr, totally 17 points)
- AUCinf of rosuvastatin and metformin(0~48hr, totally 17 points)
- Tmax of rosuvastatin and metformin(0~48hr, totally 17 points)