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

November 22, 2012 updated by: Dong-A Pharmaceutical Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Adult males aged 20 to 64 years at screening.
  2. Non-smokers
  3. In case of hepatic impaired patients
  4. In case of healthy volunteers, the subjects aged ± 10 years old of hepatic impaired patients
  5. Subjects within ±20% of the ideal body weight
  6. 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:

1.History of portosystemic shunt surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Child-Pugh A
Drug: Udenafil
100mg Single Oral Dose of Udenafil
Other Names:
  • DA-8159; Zydena
Experimental: Child-Pugh B
Drug: Udenafil
100mg Single Oral Dose of Udenafil
Other Names:
  • DA-8159; Zydena
Experimental: Healthy Volunteers
Drug: Udenafil
100mg Single Oral Dose of Udenafil
Other Names:
  • DA-8159; Zydena

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (AUC and Cmax), Safety
Time Frame: up to 72 hours
up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: HYO-SUK LEE, Ph D., Seoul National University Hospital
  • Principal Investigator: Young-Suk Lim, Ph D., Asan Medical Center, University of Ulsan Colledge of Medicine
  • Principal Investigator: Hwi Young Kim, Ph D., SMG-SNU Boramae Medical Center
  • Principal Investigator: Sook-Hyang Jeong, Ph D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 22, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA8159_HI_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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