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

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: Udenafil

• Registration Number: NCT00956306
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

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 available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-22
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Child-Pugh A	Udenafil	-
Child-Pugh B	Udenafil	-
Healthy Volunteers	Udenafil	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (AUC and Cmax), Safety	up to 72 hours

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of