NCT01874483已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 187004 CL in Patients With Type 2 Diabetes Mellitus (Randomized, Double-blind Placebo-controlled Within Dose Groups)
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
- 71
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 187004 dose 1
Experimental
multiple dose given over 14 days
干预措施: BI 187004 (Drug)
BI 187004 dose 2
Experimental
multiple dose given over 14 days
干预措施: BI 187004 (Drug)
BI 187004 dose 3
Experimental
multiple dose given over 14 days
干预措施: BI 187004 (Drug)
BI 187004 dose 4
Experimental
multiple dose given over 14 days
干预措施: BI 187004 (Drug)
BI 187004 dose 5
Experimental
multiple dose given over 14 days
干预措施: BI 187004 (Drug)
BI 187004 dose 6
Experimental
multiple dose given over 14 days
干预措施: BI 187004 (Drug)
Placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
BI 187004 dose 7
Experimental
multiple dose given over 14 days
干预措施: BI 187004 (Drug)
结局指标
主要结局
Occurrence of adverse events
时间窗: up to 15 days postdose
次要结局
- AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)(up to 8 days postdose)
- AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)(up to 8 days postdose)
- Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose)(up to 8 days postdose)
- Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)(up to 8 days postdose)
研究者
研究点 (1)
Loading locations...
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