Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT00956306
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2009-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C419664', 'term': 'udenafil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-22', 'studyFirstSubmitDate': '2009-08-10', 'studyFirstSubmitQcDate': '2009-08-10', 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (AUC and Cmax), Safety', 'timeFrame': 'up to 72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Udenafil,DA-8159,hepatic impairment,healthy volunteers'], 'conditions': ['Hepatic Impairment']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult males aged 20 to 64 years at screening.\n2. Non-smokers\n3. In case of hepatic impaired patients\n4. In case of healthy volunteers, the subjects aged ± 10 years old of hepatic impaired patients\n5. Subjects within ±20% of the ideal body weight\n6. 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.\n\nExclusion Criteria:\n\n1.History of portosystemic shunt surgery.'}, 'identificationModule': {'nctId': 'NCT00956306', 'acronym': 'udenafil', 'briefTitle': 'A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function', 'orgStudyIdInfo': {'id': 'DA8159_HI_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Child-Pugh A', 'interventionNames': ['Drug: Udenafil']}, {'type': 'EXPERIMENTAL', 'label': 'Child-Pugh B', 'interventionNames': ['Drug: Udenafil']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteers', 'interventionNames': ['Drug: Udenafil']}], 'interventions': [{'name': 'Udenafil', 'type': 'DRUG', 'otherNames': ['DA-8159; Zydena'], 'description': '100mg Single Oral Dose of Udenafil', 'armGroupLabels': ['Child-Pugh A', 'Child-Pugh B', 'Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'HYO-SUK LEE, Ph D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Young-Suk Lim, Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center, University of Ulsan Colledge of Medicine'}, {'name': 'Hwi Young Kim, Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}, {'name': 'Sook-Hyang Jeong, Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}