NCT01443429已完成1 期
A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese Patients With Renal Impairment as Compared to Subjects With Normal Renal Function
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
- 24
- 试验地点
- 1
- 主要终点
- Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax,pg/mL), area under the plasma concentration-time curve (AUC,pg·hr/mL), time at maximum concentration (Tmax,hr) and mean residence time (MRT,hr)
研究概览
简要总结
The PK and safety profiles to be examined following a single oral administration of TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to subjects with normal renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •The eGFR 1 day before study drug administration are stipulated as follows.
- •Subjects with normal renal function : ≥90
- •Patients with mild renal impairment : ≥60 to <90
- •Patients with moderate renal impairment : ≥30 to <60
- •Patients with severe renal impairment : ≥15 to <30
排除标准
- •Patients on dialysis
- •Patients who have a history of undergoing renal transplantation
- •Patients with diabetes mellitus
研究组 & 干预措施
subjects with normal renal function
Experimental
干预措施: beraprost sodium(BPS) (Drug)
patients with mild renal impairment
Experimental
干预措施: beraprost sodium(BPS) (Drug)
patients with moderate renal impairment
Experimental
干预措施: beraprost sodium(BPS) (Drug)
patients with severe renal impairment
Experimental
干预措施: beraprost sodium(BPS) (Drug)
结局指标
主要结局
Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax,pg/mL), area under the plasma concentration-time curve (AUC,pg·hr/mL), time at maximum concentration (Tmax,hr) and mean residence time (MRT,hr)
时间窗: Up to 48hr
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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