Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-01-08 @ 1:24 PM
Study NCT ID:
NCT07007533
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy Adult Subjects
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': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-05-28', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-24h', 'timeFrame': '0~12 hours', 'description': 'Area under the plasma concentration-time curve over the time interval from 0 to 24h'}, {'measure': 'Cmax', 'timeFrame': '0~12 hours', 'description': 'Peak Plasma Concentration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult']}, 'descriptionModule': {'briefSummary': 'This study will compare and evaluate the safety, tolerability and pharmacokinetics between DA-5223 and DA-5223-R in healthy adult subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female, 19 years to 55 years\n* Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2\n* The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate\n\nExclusion Criteria:\n\n* The subjects with acute illness\n* The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product\n* The subjects hypersensitive to any of the Investigational Product components or other drug components\n* The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization\n* The subjects who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT07007533', 'briefTitle': 'A Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, Crossover Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'DA5223_LSS_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'interventionNames': ['Drug: DA-5223-R', 'Drug: DA-5223']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'interventionNames': ['Drug: DA-5223-R', 'Drug: DA-5223']}], 'interventions': [{'name': 'DA-5223-R', 'type': 'DRUG', 'description': 'once a day', 'armGroupLabels': ['Sequence A', 'Sequence B']}, {'name': 'DA-5223', 'type': 'DRUG', 'description': 'once a day', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13520', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'CHA Global Clinical Trials Center', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}