Status:
COMPLETED
A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Conditions:
Hepatic Impairment
Eligibility:
MALE
20-64 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Adult males aged 20 to 64 years at screening.
- Non-smokers
- In case of hepatic impaired patients
- In case of healthy volunteers, the subjects aged ± 10 years old of hepatic impaired patients
- Subjects within ±20% of the ideal body weight
- 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
- History of portosystemic shunt surgery.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00956306
Start Date
November 1 2007
End Date
September 1 2012
Last Update
November 27 2012
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea