A Phase I, Open-label, Parallel-group Study to Investigate Pharmacokinetics, Pharmacodynamics and Safety of a Single 25 mg Dose of Empagliflozin in Japanese Type 2 Diabetes Patients With Different Degrees of Renal Impairment in Comparison to Type 2 Diabetes Patients With Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Urinary Glucose Excretion (UGE)
研究概览
简要总结
The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI10773 medium dose group 1
BI10773 medium dose tablet single dose group 1
干预措施: BI10773 (Drug)
BI10773 medium dose group 2
BI10773 medium dose tablet single dose group 2
干预措施: BI10773 (Drug)
BI10773 Medium dose group 3
BI10773 medium dose tablet single dose group 3
干预措施: BI10773 (Drug)
BI10773 Medium dose group 4
BI10773 medium dose tablet single dose group 4
干预措施: BI10773 (Drug)
结局指标
主要结局
Change From Baseline in Total Urinary Glucose Excretion (UGE)
时间窗: baseline and 24 hours
change from baseline in total urinary glucose excretion (UGE) to 24 hours
Maximum Concentration
时间窗: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
Maximum concentration of the analyte in plasma
Area Under the Concentration Time Curve of the Analyte in Plasma
时间窗: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity
次要结局
未报告次要终点