NCT00818571已完成1 期
An Open-label, Parallel Group Study to Determine the PK of 25 and 50 mg OD Single and Multiple Dose Over 14 Days, of Vildagliptin and Its Metabolites in Renal Impaired Patients Compared to Matching Healthy Volunteers
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
- 96
- 试验地点
- 1
- 主要终点
- Measure: pharmacokinetics of vildagliptin and its metabolites
研究概览
简要总结
This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with mild (CrCl from 50 to ≤80 ml/min), moderate (CrCl from 30 to <50 ml/min) and severe (CrCl of <30 ml/min) renal function, preferably type 2 diabetic and matching healthy volunteers CrCl of >80 ml/min
排除标准
- •Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications, treatment of a DPP-4 inhibitor 30 days prior to baseline, renal transplant history
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Vildagliptin 25 mg qd in Renal Impaired (RI) patients
Experimental
干预措施: Vildagliptin (Drug)
Vildagliptin 50 mg qd in RI Patients
Experimental
干预措施: Vildagliptin (Drug)
Vildagliptin 25 mg qd in matched Healthy Volunteer (HV)
Experimental
干预措施: Vildagliptin (Drug)
Vildagliptin 50 mg qd in matched HV
Experimental
干预措施: Vildagliptin (Drug)
结局指标
主要结局
Measure: pharmacokinetics of vildagliptin and its metabolites
时间窗: 14 days
次要结局
- Measure: safety assessments will include vital signs, electrocardiograms and adverse events(14 days)
研究者
研究点 (1)
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