Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-04-25 @ 2:09 PM
Study NCT ID:
NCT02369302
Status:
COMPLETED
Last Update Posted:
2016-03-01
First Post:
2015-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-27', 'studyFirstSubmitDate': '2015-02-17', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax,ss', 'timeFrame': 'Multiple blood sample will be collected for 24 hours after last dosing in each of the periods'}, {'measure': 'AUCtau', 'timeFrame': 'Multiple blood sample will be collected for 24 hours after last dosing in each of the periods'}], 'secondaryOutcomes': [{'measure': 'Cmin,ss', 'timeFrame': 'Multiple blood sample will be collected for 24 hours after last dosing in each of the periods'}, {'measure': 'Tmax', 'timeFrame': 'Multiple blood sample will be collected for 24 hours after last dosing in each of the periods'}, {'measure': 't1/2', 'timeFrame': 'Multiple blood sample will be collected for 24 hours after last dosing in each of the periods'}, {'measure': 'Metabolic Ratio', 'timeFrame': 'Multiple blood sample will be collected for 24 hours after last dosing in each of the periods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between DWC20141 and DWC20142 in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult male volunteers aged 19 to 45 years\n2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result\n3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints\n\nExclusion Criteria:\n\n1. A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.\n2. A subject who shows the following result in clinical laboratory test\n\n * AST, ALT \\> 1.25 times of the upper limit of normal range\n * PR ≥ 210 msec\n * QRS ≥ 120 msec\n * QT ≥ 500 msec\n * QTcF ≥ 500 msec\n3. Subject who has taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.'}, 'identificationModule': {'nctId': 'NCT02369302', 'briefTitle': 'Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Drug Interaction Between DWC20141 and DWC20142 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'DW_DWJ1367001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWC20141', 'description': 'multiple dose of DWC20141', 'interventionNames': ['Drug: DWC20141']}, {'type': 'EXPERIMENTAL', 'label': 'DWC20142', 'description': 'multiple dose of DWC20142', 'interventionNames': ['Drug: DWC20142']}, {'type': 'EXPERIMENTAL', 'label': 'DWC20141+DWC20142', 'description': 'multiple dose of DWC20141 and DWC20142', 'interventionNames': ['Drug: DWC20141, DWC20142']}], 'interventions': [{'name': 'DWC20141', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['DWC20141']}, {'name': 'DWC20142', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['DWC20142']}, {'name': 'DWC20141, DWC20142', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['DWC20141+DWC20142']}]}, 'contactsLocationsModule': {'locations': [{'zip': '614-735', 'city': 'Busan', 'state': 'Busanjin-gu', 'country': 'South Korea', 'facility': 'Inje University College of Medicine Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Eun-Young Kim, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BUSAN PAIK HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}