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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.
• Treatments: Udenafil

Criteria

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.