NCT02670018Unknown1 期
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg(1000 mg x 2 Tablets) Administered in Healthy Male Volunteers
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年8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
- 25
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) Administered 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)
- •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 3months
- •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
Active Comparator
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets
干预措施: gemigliptin and metformin HCl extended release (Drug)
C
Experimental
Combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets
干预措施: gemigliptin/metformin HCl extended release (Drug)
结局指标
主要结局
AUClast
时间窗: up to 48h post-dose
To evaluate AUClast of gemigliptin and metformin
Cmax
时间窗: up to 48h post-dose
To evaluate Cmax of gemigliptin and metformin
次要结局
- AUCinf of Gemigliptin, Metformin(up to 48h post-dose)
- t1/2 of Gemigliptin, Metformin(up to 48h post-dose)
- CL/F of Gemigliptin, Metformin(up to 48h post-dose)
- Vd/F of Gemigliptin, Metformin(up to 48h post-dose)
- AUC0-48h of Gemigliptin metabolite(LC15-0636)(up to 48h post-dose)
- Cmax of Gemigliptin metabolite(LC15-0636)(up to 48h post-dose)
- Tmax of Gemigliptin metabolite(LC15-0636)(up to 48h post-dose)
- AUCinf of Gemigliptin metabolite(LC15-0636)(up to 48h post-dose)
- Tmax of Gemigliptin, Metformin(up to 48h post-dose)
- t1/2 of Gemigliptin metabolite(LC15-0636)(up to 48h post-dose)
- CL/F of Gemigliptin metabolite(LC15-0636)(up to 48h post-dose)
- Vd/F of Gemigliptin metabolite(LC15-0636)(up to 48h post-dose)
- metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636)(up to 48h post-dose)
研究者
研究点 (1)
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