Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-04 @ 5:41 PM
Study NCT ID:
NCT06109259
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2023-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult 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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-29', 'studyFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2023-10-29', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax,ss of DWJ1567 and DWC202312', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0 to 72 hour.'}, {'measure': 'AUCt of DWJ1567 and DWC202312', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0 to 72 hour.'}], 'secondaryOutcomes': [{'measure': 'AUCinf of DWJ1567 and DWC202312', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0 to 72 hour'}, {'measure': 'Tmax of DWJ1567 and DWC202312', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0 to 72 hour'}, {'measure': 'AUCt/AUCinf of DWJ1567 and DWC202312', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0 to 72 hour'}, {'measure': 't1/2 of DWJ1567 and DWC202312', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0 to 72 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the pharmacokinetics and safety following administration of DWJ1567 and DWC202312 in healthy volunteers', 'detailedDescription': 'The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1567 and DWC202312. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1567 and DWC202312.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 19 year old\n\nExclusion Criteria:\n\n* Galactose intolerance\n* Lapp lactase deficiency'}, 'identificationModule': {'nctId': 'NCT06109259', 'briefTitle': 'Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1567 and DWC202312 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DWJ1567101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWJ1567', 'description': 'DWJ1567', 'interventionNames': ['Drug: DWJ1567']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DWC202312', 'description': 'DWC202312', 'interventionNames': ['Drug: DWC202312']}], 'interventions': [{'name': 'DWJ1567', 'type': 'DRUG', 'description': 'One tablet of DWJ1567', 'armGroupLabels': ['DWJ1567']}, {'name': 'DWC202312', 'type': 'DRUG', 'description': 'One tablet of DWC202312', 'armGroupLabels': ['DWC202312']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Hyun Kang', 'role': 'CONTACT', 'email': 'juspa@newyjh.com', 'phone': '070-4665-9490'}], 'facility': 'H Plus YANGJI Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Seung-Hyun Kang, MD, Ph D', 'role': 'CONTACT', 'email': 'juspa@newyjh.com', 'phone': '070-4665-9490'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}