NCT01232010已完成1 期
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
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
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (AUC and Cmax)
研究概览
简要总结
This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males aged 19 to 64 years at screening.
- •Subjects with body weight ≥ 50 kg and within ±30% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.
- •Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
排除标准
- •Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
- •Subjects with hypotension or hypertension.
- •Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
研究组 & 干预措施
Healthy Volunteers
Experimental
干预措施: Mirodenafil (Drug)
Patients with severe renal impairment
Experimental
干预措施: Mirodenafil (Drug)
结局指标
主要结局
Pharmacokinetics (AUC and Cmax)
时间窗: 2days
次要结局
未报告次要终点
研究者
Kyun-Seop Bae
Principal Investigator
Asan Medical Center
研究点 (1)
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