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Completed

NCT Number: NCT00956306

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

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.

Completed

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Key information

Conditions

Hepatic Impairment

Age range

20 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

1.History of portosystemic shunt surgery.

Treatment and study plan

Udenafil

Drug

100mg Single Oral Dose of Udenafil

Other names: DA-8159; Zydena

Primary outcomes

  1. Pharmacokinetics (AUC and Cmax), Safety

    Time frame: up to 72 hours

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Industry

Registry information

Acronym: udenafil

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 11, 2009
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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