NCT02214693已完成1 期
A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area Under Curve(AUC) last
研究概览
简要总结
This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 20 and 70
- •Weights between 50 and 90kg(Female : 40 and 90kg)
- •Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress
- •Stable results of estimated GFR in 4 months recently
排除标准
- •Volunteer 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)
- •Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction
- •Volunteer who already participated in other trials in 2 months
- •Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
研究组 & 干预措施
Group 1(Severe decrease in GFR)
Experimental
Severe decrease in GFR
干预措施: DA-1229 (Drug)
Group 2(Moderate decrease in GFR)
Experimental
Moderate decrease in GFR
干预措施: DA-1229 (Drug)
Group 3(Mild decrease in GFR)
Experimental
Mild decrease in GFR
干预措施: DA-1229 (Drug)
Group 4(Normal GFR)
Experimental
Normal GFR
干预措施: DA-1229 (Drug)
结局指标
主要结局
Area Under Curve(AUC) last
时间窗: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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