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

Dong-A Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Udenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00956306

DA8159_HI_I

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Child-Pugh A

Experimental group

Treatment:

Drug: Udenafil

Child-Pugh B

Experimental group

Treatment:

Drug: Udenafil

Healthy Volunteers

Experimental group

Treatment:

Drug: Udenafil