Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT07260851
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting Conditions
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': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'At pre-dose (0 hours), and post-dose 1 to 72 hours.', 'description': 'Cmax of DWJ1622 and DWC202313, DWC202314'}, {'measure': 'AUClast', 'timeFrame': 'At pre-dose (0 hours), and post-dose 1 to 72 hours.', 'description': 'AUClast of DWJ1622 and DWC202313, DWC202314'}], 'secondaryOutcomes': [{'measure': 'AUCinf', 'timeFrame': 'At pre-dose (0 hours), and post-dose 1 to 72 hours.', 'description': 'AUCinf of DWJ1622 and DWC202313, DWC202314'}, {'measure': 'AUClast/AUCinf', 'timeFrame': 'At pre-dose (0 hours), and post-dose 1 to 72 hours.', 'description': 'AUClast/AUCinf of DWJ1622 and DWC202313, DWC202314'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fasting conditions.', 'detailedDescription': 'This is an open-label, randomized, oral, single-dose, 2-sequence, 2-period, crossover Phase 1 study designed to compare the pharmacokinetics and safety profiles of DWJ1622 with the co-administration of DWC202313 and DWC202314 in healthy volunteers under fasting conditions. Subjects will be randomized to receive either DWJ1622 or the co-administration of DWC202313 and DWC202314 in different sequences across two study periods with an appropriate washout period.\n\nThe primary pharmacokinetic endpoints include the maximum observed plasma concentration (Cmax) and the area under the plasma concentration-time curve to the last measurable concentration (AUClast) of each study drug. Secondary endpoints include the area under the plasma concentration-time curve extrapolated to infinity (AUCinf), the ratio of AUClast to AUCinf (AUClast/AUCinf), the time to reach maximum plasma concentration (Tmax), and the terminal elimination half-life (t1/2). Safety will be evaluated based on adverse events and clinical laboratory tests.'}, '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': 'NCT07260851', 'briefTitle': 'Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "DWJ1622" and Co-administration of "DWC202313" and "DWC202314" in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWJ1622102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWJ1622', 'interventionNames': ['Drug: DWJ1622', 'Drug: DWC202313, DWC202314']}, {'type': 'EXPERIMENTAL', 'label': 'DWC202313, DWC202314', 'interventionNames': ['Drug: DWJ1622', 'Drug: DWC202313, DWC202314']}], 'interventions': [{'name': 'DWJ1622', 'type': 'DRUG', 'description': 'DWJ1622 (single oral dose) is administered in accordance with the study protocol.', 'armGroupLabels': ['DWC202313, DWC202314', 'DWJ1622']}, {'name': 'DWC202313, DWC202314', 'type': 'DRUG', 'description': 'DWC202313, DWC202314(single oral dose) is administered in accordance with the study protocol.', 'armGroupLabels': ['DWC202313, DWC202314', 'DWJ1622']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08779', 'city': 'Seoul', 'state': 'Gwanak-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bae', 'role': 'CONTACT', 'phone': '8218778875'}], 'facility': 'H Plus YANGJI Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'SHIN', 'role': 'CONTACT', 'email': 'hbshin028@daewoong.co.kr', 'phone': '825508858'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}