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A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function

NCT00956306 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-11-27

No results posted yet for this study

Summary

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

Conditions

  • Hepatic Impairment

Interventions

DRUG

Udenafil

100mg Single Oral Dose of Udenafil

Sponsors & Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • HYO-SUK LEE, Ph D. · Seoul National University Hospital

  • Young-Suk Lim, Ph D. · Asan Medical Center, University of Ulsan Colledge of Medicine

  • Hwi Young Kim, Ph D. · SMG-SNU Boramae Medical Center

  • Sook-Hyang Jeong, Ph D. · Seoul National University Bundang Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00956306 on ClinicalTrials.gov