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NCT00956306 Clinical Trial

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

Hepatic Impairment Clinical Trial

— udenafil  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00956306
Other study ID # DA8159_HI_I
Secondary ID
Status Completed
Phase Phase 1
First received August 10, 2009
Last updated November 22, 2012
Start date November 2007
Est. completion date September 2012

Study information
Verified date November 2012
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 64 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• Udenafil
100mg Single Oral Dose of Udenafil

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics (AUC and Cmax), Safety up to 72 hours Yes
See also
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