Skip to main content
OpenTrials
Completed

NCT Number: NCT01231997

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

This study is designed to assess the effect of renal impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with renal impairment compared to healthy subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

19 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult males aged 19 to 64 years at screening.
  • Subjects with body weight ≥ 55 kg and within ±30% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
  • 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.

Exclusion criteria

  • Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
  • Subjects with hypotension or hypertension.
  • Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
  • Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Treatment and study plan

Udenafil

Drug

100mg Single Oral Dose of

Primary outcomes

  1. Pharmacokinetics (AUC and Cmax)

    Time frame: up to 48 hours

Secondary outcomes

  1. Safety

    Time frame: up to 48 hours

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

Registry information

Acronym: DA8159_RI_I

Important dates

Study start
2009
Primary completion
2010
First posted
Nov 2, 2010
Registry last updated
Nov 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.