Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-29 @ 4:04 PM
Study NCT ID:
NCT01241032
Status:
COMPLETED
Last Update Posted:
2010-11-16
First Post:
2010-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study to Investigate the Alcohol Interaction of DA8159
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C419664', 'term': 'udenafil'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'lastUpdateSubmitDate': '2010-11-15', 'studyFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (AUC and Cmax)', 'timeFrame': '48 Hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DA-8159', 'Udenafil', 'Alcohol'], 'conditions': ['Healthy Volunteers', 'Erectile Dysfunction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://crc.amc.seoul.kr', 'label': 'Clinical Research Center, Asan Medical Center'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males aged 19 to 55 years at screening.\n* Subjects with body weight ≥ 55 kg and within ±20% of the ideal body weight : Ideal body weight = (height \\[cm\\] - 100)x0.9.\n* 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\n* Subjects with the test results of QTc \\> 430 ms or non-sinus cardiac rhythm by ECG analysis.\n* Subjects with hypotension or hypertension.\n* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.\n* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.'}, 'identificationModule': {'nctId': 'NCT01241032', 'acronym': 'DA8159_DIA_I', 'briefTitle': 'Phase I Study to Investigate the Alcohol Interaction of DA8159', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Alcohol on the Pharmacokinetics of Udenafil Tablet in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': '2006-0086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Udenafil', 'description': 'Udenafil 200mg', 'interventionNames': ['Drug: Udenafil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Udenafil + Alcohol', 'description': 'Udenafil 200mg + Alcohol', 'interventionNames': ['Drug: Udenafil', 'Dietary Supplement: Alcohol']}], 'interventions': [{'name': 'Udenafil', 'type': 'DRUG', 'description': '200mg Single Oral Dose of', 'armGroupLabels': ['Udenafil', 'Udenafil + Alcohol']}, {'name': 'Alcohol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Alcohol 39g / 240ml', 'armGroupLabels': ['Udenafil + Alcohol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyun-Seop Bae, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dong-A Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Clinical Development Team1', 'oldOrganization': 'Dong-A Pharmaceutical Co., Ltd.'}}}}