Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-27 @ 1:28 AM
Study NCT ID:
NCT01606059
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2012-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-11', 'studyFirstSubmitDate': '2012-05-23', 'studyFirstSubmitQcDate': '2012-05-23', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC of DW-0919(Acetaminophen, Tramadol)', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36'}, {'measure': 'Cmax of DW-0919(Acetaminophen, Tramadol)', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36'}, {'measure': 'AUC of DW-0920(Acetaminophen, Tramadol)', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36'}, {'measure': 'Cmax of DW-0920(Acetaminophen, Tramadol)', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '35800670', 'type': 'DERIVED', 'citation': 'Kim HC, Yoon DY, Lee S, Jang IJ, Hong JH, Kim J. Comparative pharmacokinetics between two tablets of tramadol 37.5 mg/acetaminophen 325 mg and one tablet of tramadol 75 mg/acetaminophen 650 mg for extended-release fixed-dose combination. Transl Clin Pharmacol. 2022 Jun;30(2):112-119. doi: 10.12793/tcp.2022.30.e12. Epub 2022 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males aged 20 to 55 years at screening.\n* No significant congenital/chronic disease.\n* No symptoms in physical examination.\n* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.\n* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.\n\nExclusion Criteria:\n\n* History of Hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids.\n* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.\n* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.'}, 'identificationModule': {'nctId': 'NCT01606059', 'acronym': 'DW0919-1003', 'briefTitle': 'Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Open Label, 2-treatment, 2-sequence, Cross-over Study to Compare the Safety and Pharmacokinetics of DW-0919 and DW-0920 After Single Oral Administration in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DW0919-1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DW-0919', 'interventionNames': ['Drug: DW-0919']}, {'type': 'EXPERIMENTAL', 'label': 'DW-0920', 'interventionNames': ['Drug: DW-0920']}], 'interventions': [{'name': 'DW-0920', 'type': 'DRUG', 'otherNames': ['Acetaminophen: 325mg', 'Tramadol: 37.5mg', 'Wontran ER tab.'], 'description': 'Dosage form: Extended release tablet Dosage: 2 tablets', 'armGroupLabels': ['DW-0920']}, {'name': 'DW-0919', 'type': 'DRUG', 'otherNames': ['Acetaminophen: 650mg', 'Tramadol: 75mg'], 'description': 'Dosage form: Extended release tablet Dosage: 1 tablet', 'armGroupLabels': ['DW-0919']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chungnam National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}