We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956306
First Posted: August 11, 2009
Last Update Posted: November 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )
  Purpose
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.

Condition Intervention Phase
Hepatic Impairment Drug: Udenafil Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function

Further study details as provided by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ):

Primary Outcome Measures:
  • Pharmacokinetics (AUC and Cmax), Safety [ Time Frame: up to 72 hours ]

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Child-Pugh A Drug: Udenafil
100mg Single Oral Dose of Udenafil
Other Name: DA-8159; Zydena
Experimental: Child-Pugh B Drug: Udenafil
100mg Single Oral Dose of Udenafil
Other Name: DA-8159; Zydena
Experimental: Healthy Volunteers Drug: Udenafil
100mg Single Oral Dose of Udenafil
Other Name: DA-8159; Zydena

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956306


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
Study Chair: HYO-SUK LEE, Ph D. Seoul National University Hospital
Principal Investigator: Young-Suk Lim, Ph D. Asan Medical Center, University of Ulsan Colledge of Medicine
Principal Investigator: Hwi Young Kim, Ph D. SMG-SNU Boramae Medical Center
Principal Investigator: Sook-Hyang Jeong, Ph D. Seoul National University Bundang Hospital
  More Information

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00956306     History of Changes
Other Study ID Numbers: DA8159_HI_I
First Submitted: August 10, 2009
First Posted: August 11, 2009
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ):
Udenafil,DA-8159,hepatic impairment,healthy volunteers

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action