NCT02670070Unknown1 期
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of the Combination of Gemigliptin/Rosuvastatin 50/20 mg in Comparison to Each Component Gemigliptin 50 mg and Rosuvastatin 20 mg Administered in Healthy Male Volunteers
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- AUClast, Cmax
研究概览
简要总结
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.
详细描述
This study is to evaluate the safety/tolerability and pharmacokinetics(AUC and Cmax) of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 19 to 45, healthy male subjects(at screening)
- •BMI between 18.0 - 27.0
- •FPG 70-125mg/dL glucose level(at screening)
- •Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
排除标准
- •Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- •Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- •Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
- •Subject who already participated in other trials in 2months
- •Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.
- •Heavy smokers.(>10 cigarettes per day)
研究组 & 干预措施
Coadministration of G+R
Active Comparator
Coadministration of gemigliptin 50mg and rosuvastatin 20mg
干预措施: gemigliptin 50mg, rosuvastatin 20mg (Drug)
Combination G/R
Experimental
Combination of gemigliptin 50mg / rosuvastatin 20mg
干预措施: gemigliptin 50mg, rosuvastatin 20mg (Drug)
结局指标
主要结局
AUClast, Cmax
时间窗: up to 72h post-dose
To evaluate AUClast/Cmax of gemigliptin and rosuvastatin
次要结局
- Tmax(up to 72h post-dose)
- t1/2(up to 72h post-dose)
- CL/F(up to 72h post-dose)
- AUCinf(up to 72h post-dose)
- metabolic ratio(up to 72h post-dose)
- AUEC(up to 72h post-dose)
- Emax(up to 72h post-dose)
研究者
研究点 (1)
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