Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT04819932
Status:
UNKNOWN
Last Update Posted:
2021-03-29
First Post:
2021-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of DWJ1451 in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-04-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-25', 'studyFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameter of DWJ1451:AUC0-t', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Area under the plasma xonxentration-time curve from time 0 to t'}, {'measure': 'Pharmacokinetic parameter of DWJ1451:Cmax', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Maximum plasma drug concentration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Amlodipine, olmesartan, total ezetimibe, rosuvastatin AUCt, Cmax'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 to 55 years\n* Healthy Adult\n\nExclusion Criteria:\n\n* Non-Healthy'}, 'identificationModule': {'nctId': 'NCT04819932', 'briefTitle': 'Pharmacokinetics and Safety of DWJ1451 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'An Open-label, Randomized, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1451 and Co-administration of DWC202008 and DWC202009 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWJ1451102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group1', 'description': 'subject take DWC202008 and DWC2020091 on a fasted condition, and after wash out period, take DWJ1451 with on a fasted condition', 'interventionNames': ['Drug: DWJ1451']}, {'type': 'EXPERIMENTAL', 'label': 'group2', 'description': 'subject take DWJ1451 on a fasted condition, and after wash out period, take DWC202008 and DWC202009 with on a fasted condition', 'interventionNames': ['Drug: DWJ1451']}], 'interventions': [{'name': 'DWJ1451', 'type': 'DRUG', 'description': 'DWC202008 DWC202009', 'armGroupLabels': ['group1', 'group2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54907', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}