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

Primary Purpose

Hepatic Impairment

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Udenafil
Sponsored by
Dong-A Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hepatic Impairment focused on measuring Udenafil,DA-8159,hepatic impairment,healthy volunteers

Eligibility Criteria

20 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Child-Pugh A

Child-Pugh B

Healthy Volunteers

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetics (AUC and Cmax), Safety

Secondary Outcome Measures

Full Information

First Posted
August 10, 2009
Last Updated
November 22, 2012
Sponsor
Dong-A Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00956306
Brief Title
A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function
Acronym
udenafil
Official Title
A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
Keywords
Udenafil,DA-8159,hepatic impairment,healthy volunteers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child-Pugh A
Arm Type
Experimental
Arm Title
Child-Pugh B
Arm Type
Experimental
Arm Title
Healthy Volunteers
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Udenafil
Other Intervention Name(s)
DA-8159; Zydena
Intervention Description
100mg Single Oral Dose of Udenafil
Primary Outcome Measure Information:
Title
Pharmacokinetics (AUC and Cmax), Safety
Time Frame
up to 72 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult males aged 20 to 64 years at screening. Non-smokers In case of hepatic impaired patients In case of healthy volunteers, the subjects aged ± 10 years old of hepatic impaired patients Subjects within ±20% of the ideal body weight 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HYO-SUK LEE, Ph D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Young-Suk Lim, Ph D.
Organizational Affiliation
Asan Medical Center, University of Ulsan Colledge of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hwi Young Kim, Ph D.
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sook-Hyang Jeong, Ph D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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