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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00956306
First received: August 10, 2009
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 Pharmaceutical Co., Ltd.:

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

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

Ages Eligible for Study:   20 Years to 64 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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. Seoul National University Boramae Medical Center
Principal Investigator: Sook-Hyang Jeong, Ph D. Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00956306     History of Changes
Other Study ID Numbers: DA8159_HI_I
Study First Received: August 10, 2009
Last Updated: November 22, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013