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

NCT01231997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2010-11-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Udenafil

100mg Single Oral Dose of

Sponsors & Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Kyun-Seop Bae, M.D., Ph.D. · Asan Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT01231997 on ClinicalTrials.gov