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2009年11月

适应症Renal Insufficiency Kidney Diseases Urologic Diseases

干预措施Mirodenafil

概览

阶段: 1 期
干预措施: Mirodenafil
疾病 / 适应症: Renal Insufficiency
发起方: Asan Medical Center
入组人数: 12
试验地点: 1
主要终点: Pharmacokinetics (AUC and Cmax)
状态: 已完成
最后更新: 11年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2009年11月

结束日期

2011年12月

最后更新

11年前

研究类型

Interventional

研究设计

Parallel

性别

Male

研究者

发起方

Asan Medical Center

责任方

Principal Investigator

主要研究者

Kyun-Seop Bae

Principal Investigator

Asan Medical Center

入排标准

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.