临床试验/NCT01232010

NCT01232010已完成1 期

Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

Asan Medical Center1 个研究点分布在 1 个国家目标入组 12 人开始时间: 2009年11月最近更新: 2015年1月15日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Asan Medical Center
入组人数: 12
试验地点: 1
主要终点: Pharmacokinetics (AUC and Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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

发起方

Asan Medical Center

申办方类型

Other

责任方

Principal Investigator

主要研究者

Kyun-Seop Bae

Principal Investigator

Asan Medical Center

研究点 (1)

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