NCT00567047已完成1 期
An Open-Label, Parallel-Group Study to Determine the Single and Multiple Dose Pharmacokinetics of Vildagliptin and Its Metabolites in Mild, Moderate or Severe Renal Impaired Patients Compared to Age, Sex and Weight-Matched Healthy Volunteers Following Daily Doses of 50 mg Vildagliptin for 14 Days
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
- Novartis
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- • Pharmacokinetic measures
研究概览
简要总结
This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Vildagliptin
干预措施: vildagliptin (Drug)
结局指标
主要结局
• Pharmacokinetic measures
时间窗: throughout the study
次要结局
- • Safety and tolerability measures(throughout the study)
研究者
研究点 (1)
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