jRCT2080224863已完成2 期
A multi-center, open-label clinical pharmacology study to evaluate the pharmacokinetics, pharmacodynamics and safety of TMX-049 multiple oral administration in subjects with normal renal function or impaired renal function.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plasma TEI-R04969(unchanged drug)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Open-label
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 75age old under（—）
- 性别
- Male
入选标准
- •Estimated eGFR(mL/min/1.73 m2) * within the categories shown below
- •Severe renal impairment: 10 =< eGFR < 30
- •Moderate renal impairment: 30 =< eGFR < 60
- •Normal renal function: 90 =< eGFR
- •: calculated using the eGFRcreat Formula
- •Serum urate => 5.0 mg/dL
排除标准
- •Patients who have gouty arthritis
- •Patients who have malignant tumor
- •Patients who have severe hepatic insufficiency
- •Patients who have poor blood pressure control
- •Patients who have poor glycaemic control
结局指标
主要结局
Plasma TEI-R04969(unchanged drug)
Plasma TEI-R04969(unchanged drug)
Urinary TEI-R04969(unchanged drug)
Urinary TEI-R04969(unchanged drug)
protein binding ratio
protein binding ratio
Serum urate
Serum urate
Adverse events
Adverse events
Clinical laboratory tests
Clinical laboratory tests
Vital signs
Vital signs
Standard 12-lead ECG
Standard 12-lead ECG
次要结局
未报告次要终点
研究者
研究点 (1)
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