Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 2:34 AM
Study NCT ID:
NCT05449704
Status:
UNKNOWN
Last Update Posted:
2022-07-08
First Post:
2022-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers
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': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-09-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-04', 'studyFirstSubmitDate': '2022-07-04', 'studyFirstSubmitQcDate': '2022-07-04', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt', 'timeFrame': 'pre-dose~72 hours post-dose', 'description': 'area under the curve'}, {'measure': 'Cmax', 'timeFrame': 'pre-dose~72 hours post-dose', 'description': 'maximum plasma concentration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Pharmacokinetics and safety Profiles after administration of DA-5218 and co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in healthy adult volunteers'}, '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* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study\n\nExclusion Criteria:\n\n* Subjects with allergy or drug hypersensitivity\n* Subjects with clinically significant medical history\n* Subjects with history of drug abuse or addicted'}, 'identificationModule': {'nctId': 'NCT05449704', 'briefTitle': 'Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'DA5218_BE_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'interventionNames': ['Drug: DA-5218', 'Drug: DA-5218-R1 + DA-5218-R2 + DA-5218-R3']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'interventionNames': ['Drug: DA-5218', 'Drug: DA-5218-R1 + DA-5218-R2 + DA-5218-R3']}], 'interventions': [{'name': 'DA-5218', 'type': 'DRUG', 'description': 'single dose administration (DA-5218 one tablet once a day)', 'armGroupLabels': ['Sequence A', 'Sequence B']}, {'name': 'DA-5218-R1 + DA-5218-R2 + DA-5218-R3', 'type': 'DRUG', 'description': 'single dose administration (DA-5218-R1 one tablet once a day + DA-5218-R2 one tablet once a day + DA-5218-R3 one tablet once a day)', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07590', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'TaeGon Hong, Ph.D', 'role': 'CONTACT', 'email': 'tghong@bumin.co.kr'}], 'facility': 'Bumin Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'JiHyun Sung', 'role': 'CONTACT', 'email': 'jhsung@donga.co.kr', 'phone': '+82-2-920-8369'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}