Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT05106205
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2021-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy 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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2021-10-24', 'studyFirstSubmitQcDate': '2021-11-01', 'lastUpdatePostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt', 'timeFrame': '[Time Frame: pre-dose~48 hours post-dose]', 'description': 'area under the curve'}, {'measure': 'Cmax', 'timeFrame': '[Time Frame: pre-dose~48 hours post-dose]', 'description': 'maximum plasma concentration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteers\n* BMI between 18.0 and 30.0 kg/m2\n* Body weight : Male≥50kg, Female≥45kg\n\nExclusion Criteria:\n\n* Allergy or Drug hypersensitivity\n* Clinically significant Medical History'}, 'identificationModule': {'nctId': 'NCT05106205', 'briefTitle': 'Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5213 10mg in Healthy Subjects', 'orgStudyIdInfo': {'id': 'BIBE2021-55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'interventionNames': ['Drug: DA-5213 10mg', 'Drug: DA-5213-R 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'interventionNames': ['Drug: DA-5213 10mg', 'Drug: DA-5213-R 10mg']}], 'interventions': [{'name': 'DA-5213 10mg', 'type': 'DRUG', 'description': 'single dose administration (one tablet once a day)', 'armGroupLabels': ['Sequence A', 'Sequence B']}, {'name': 'DA-5213-R 10mg', 'type': 'DRUG', 'description': 'single dose administration (one tablet once a day)', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15079', 'city': 'Siheung-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}