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

NCT ID: NCT00956306

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Hepatic Impairment

Keywords

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Udenafil,DA-8159,hepatic impairment,healthy volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Child-Pugh A

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

100mg Single Oral Dose of Udenafil

Child-Pugh B

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

100mg Single Oral Dose of Udenafil

Healthy Volunteers

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

100mg Single Oral Dose of Udenafil

Interventions

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Udenafil

100mg Single Oral Dose of Udenafil

Intervention Type DRUG

Other Intervention Names

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DA-8159; Zydena

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HYO-SUK LEE, Ph D.

Role: STUDY_CHAIR

Seoul National University Hospital

Young-Suk Lim, Ph D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center, University of Ulsan Colledge of Medicine

Hwi Young Kim, Ph D.

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Sook-Hyang Jeong, Ph D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA8159_HI_I

Identifier Type: -

Identifier Source: org_study_id