Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-28 @ 10:57 PM
Study NCT ID:
NCT05739903
Status:
UNKNOWN
Last Update Posted:
2023-02-22
First Post:
2023-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007854', 'term': 'Lead'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-04-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt', 'timeFrame': 'pre-dose~96 hours post-dose', 'description': 'area under the curve'}, {'measure': 'Cmax', 'timeFrame': 'pre-dose~96 hours post-dose', 'description': 'maximum plasma concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\\_01 (5/1000 mg x1 tablets) at fasting state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteers\n* BMI between 18 and 30 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': 'NCT05739903', 'briefTitle': 'Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'An Open Label, Randomized, Single Dose, Cross-over ,Two-group Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State', 'orgStudyIdInfo': {'id': '22-4249-BE024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A(Before→ After)', 'interventionNames': ['Drug: DA-1229_01 5/1000mg (Before)', 'Drug: DA-1229_01 5/1000mg (After)']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B(After→ Before)', 'interventionNames': ['Drug: DA-1229_01 5/1000mg (Before)', 'Drug: DA-1229_01 5/1000mg (After)']}], 'interventions': [{'name': 'DA-1229_01 5/1000mg (Before)', 'type': 'DRUG', 'description': 'single dose administration (one tablet once a day)', 'armGroupLabels': ['Sequence A(Before→ After)', 'Sequence B(After→ Before)']}, {'name': 'DA-1229_01 5/1000mg (After)', 'type': 'DRUG', 'description': 'single dose administration (one tablet once a day)', 'armGroupLabels': ['Sequence A(Before→ After)', 'Sequence B(After→ Before)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14096', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Metro Hospital', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}