A Pharmacokinetic Study of Udenafil in Adult Subjects Wit... | NCT00956306

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

NCT00956306

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Nov 27, 2012Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Hepatic Impairment

Interventions

Udenafil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Aug 10, 2009

First Submission Date that Met QC Criteria

Aug 10, 2009

First Posted Date

Aug 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2012

Last Update Posted Date

Nov 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Child-Pugh A	Experimental	Drug: Udenafil
Child-Pugh B	Experimental	Drug: Udenafil
Healthy Volunteers	Experimental	Drug: Udenafil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Udenafil	Drug	100mg Single Oral Dose of Udenafil	Child-Pugh A Child-Pugh B Healthy Volunteers

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

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
HYO-SUK LEE, Ph D.	Seoul National University Hospital	Study Chair
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C419664	udenafil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided