Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-19 @ 3:42 PM
Study NCT ID:
NCT06592495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-23
First Post:
2024-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315
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': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The maximum serum concentration(Cmax) of DWJ1589 and DWC202315', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0.83 to 72 hour.', 'description': 'Cmax of DWJ1589 and DWC202315'}, {'measure': 'The Area under the curve(AUC)last of DWJ1589 and DWC202315', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0.83 to 72 hour.', 'description': 'AUClast of DWJ1589 and DWC202315'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.', 'detailedDescription': 'The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 19 year old\n* Healthy adult volunteers\n\nExclusion Criteria:\n\n* with a history of mental disorder\n* For female volunteers, those who are suspected of being pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT06592495', 'briefTitle': 'Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'DW_DWJ1589101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A: RTRT', 'description': 'T: DWJ1589 R: DWC202315', 'interventionNames': ['Drug: Period 1', 'Drug: Period 2', 'Drug: Period 3', 'Drug: Period 4']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B: TRTR', 'description': 'T: DWJ1589 R: DWC202315', 'interventionNames': ['Drug: Period 1', 'Drug: Period 2', 'Drug: Period 3', 'Drug: Period 4']}], 'interventions': [{'name': 'Period 1', 'type': 'DRUG', 'description': 'DWJ1589 or DWC202315', 'armGroupLabels': ['Sequence A: RTRT', 'Sequence B: TRTR']}, {'name': 'Period 2', 'type': 'DRUG', 'description': 'DWJ1589 or DWC202315', 'armGroupLabels': ['Sequence A: RTRT', 'Sequence B: TRTR']}, {'name': 'Period 3', 'type': 'DRUG', 'description': 'DWJ1589 or DWC202315', 'armGroupLabels': ['Sequence A: RTRT', 'Sequence B: TRTR']}, {'name': 'Period 4', 'type': 'DRUG', 'description': 'DWJ1589 or DWC202315', 'armGroupLabels': ['Sequence A: RTRT', 'Sequence B: TRTR']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'SHIN, CPL', 'role': 'CONTACT', 'phone': '02-550-8858'}], 'overallOfficials': [{'name': 'KANG, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H Plus Yangji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}