NCT01595880已完成1 期
A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone in Healthy Male Volunteers
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 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 metformin HCl extended release 500mg 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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 20 to 45, healthy male subjects(at screening)
- •Body weight between 55kg - 90kg, 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 2months, or component blood donation in 1months or transfusion in 1months currently.
- •Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
研究组 & 干预措施
G+M
Experimental
Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg
干预措施: gemigliptin and metformin HCl extended release (Drug)
C
Experimental
Combination of gemigliptin50mg/metformin HCl extended release 500mg
干预措施: gemigliptin/metformin HCl extended release (Drug)
结局指标
主要结局
AUClast, Cmax
时间窗: up to 48h post-dose
To evaluate AUClast and Cmax of gemigliptin and metformin
次要结局
- AUCinf, Tmax, t1/2, CL/F, metabolic ratio(up to 48h post-dose)
研究者
研究点 (1)
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