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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00956306

Acronym

udenafil

Enrollment

Registered

2009-08-11

Start date

2007-11-30

Completion date

2012-09-30

Last updated

2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Udenafil,DA-8159,hepatic impairment,healthy volunteers

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.

Interventions

DRUGUdenafil

100mg Single Oral Dose of Udenafil

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026