Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT06119958
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-05', 'studyFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2023-11-05', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax,ss of DWC202313 and DWC202314', 'timeFrame': 'Up to 14 days'}, {'measure': 'AUCt,ss of DWC202313 and DWC202314', 'timeFrame': 'Up to 14 days'}], 'secondaryOutcomes': [{'measure': 'Tmax,ss of DWC202313 and DWC202314', 'timeFrame': 'Up to 14 days'}, {'measure': 'Cmin,ss of DWC202313 and DWC202314', 'timeFrame': 'Up to 14 days'}, {'measure': 't1/2 of DWC202313 and DWC202314', 'timeFrame': 'Up to 14 days'}, {'measure': 'CLss/F of DWC202313 and DWC202314', 'timeFrame': 'Up to 14 days'}, {'measure': 'Vdss/F of DWC202313 and DWC202314', 'timeFrame': 'Up to 14 days'}, {'measure': 'PTF of DWC202313 and DWC202314', 'timeFrame': 'Up to 14 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Drug Interaction']}, 'descriptionModule': {'briefSummary': 'This is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', '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': 'NCT06119958', 'briefTitle': 'Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of DWC202313 and DWC202314 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'DWJ1622101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWC202313', 'description': 'DWC202313', 'interventionNames': ['Drug: DWC202313']}, {'type': 'EXPERIMENTAL', 'label': 'DWC202314', 'description': 'DWC202314', 'interventionNames': ['Drug: DWC202314']}], 'interventions': [{'name': 'DWC202313', 'type': 'DRUG', 'description': 'Experimental Drug 1', 'armGroupLabels': ['DWC202313']}, {'name': 'DWC202314', 'type': 'DRUG', 'description': 'Experimental Drug 2', 'armGroupLabels': ['DWC202314']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Hyun Kang, MD, Ph D.', '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'}}}}