Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 5:49 PM
Study NCT ID:
NCT07382661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Between DW4421 and Amoxicillin/Clarithromycin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax,ss: Maximum concentration of DW4421, DW4421-1 and DW4421-2 at steady state', 'timeFrame': 'Up to day 6 or day 7'}, {'measure': 'AUCĪ,ss: Area under the drug concentration-time curve of DW4421, DW4421-1, DW4421-2 within a dosing interval at steady state', 'timeFrame': 'Up to day 6 or day 7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Volunteers']}, 'descriptionModule': {'briefSummary': 'Drug-Drug Interaction between DW4421 and Amoxicillin/Clarithromycin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria:\n* Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.\n* Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.\n\nExclusion Criteria:\n\n* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.'}, 'identificationModule': {'nctId': 'NCT07382661', 'briefTitle': 'Drug-Drug Interaction Between DW4421 and Amoxicillin/Clarithromycin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetics Drug-drug Interaction of DW4421 and Amoxicillin/Clarithromycin in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'DW4421-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'A-B-C (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)', 'interventionNames': ['Drug: DW4421', 'Drug: DW4421-1', 'Drug: DW4421-2']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'A-C-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)', 'interventionNames': ['Drug: DW4421', 'Drug: DW4421-1', 'Drug: DW4421-2']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'B-A-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)', 'interventionNames': ['Drug: DW4421', 'Drug: DW4421-1', 'Drug: DW4421-2']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'B-C-A (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)', 'interventionNames': ['Drug: DW4421', 'Drug: DW4421-1', 'Drug: DW4421-2']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5', 'description': 'C-A-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)', 'interventionNames': ['Drug: DW4421', 'Drug: DW4421-1', 'Drug: DW4421-2']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6', 'description': 'C-B-A (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)', 'interventionNames': ['Drug: DW4421', 'Drug: DW4421-1', 'Drug: DW4421-2']}], 'interventions': [{'name': 'DW4421', 'type': 'DRUG', 'description': '1 tablet will be orally administered', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'DW4421-1', 'type': 'DRUG', 'description': '2 capsules will be orally administered', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'DW4421-2', 'type': 'DRUG', 'description': '1 tablet will be orally administered', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cheongju-si', 'state': 'North Chungcheong', 'country': 'South Korea', 'contacts': [{'name': 'Chungbuk National University Hospital', 'role': 'CONTACT', 'email': 'cbnuhirb@naver.com', 'phone': '+82-43-269-6771'}], 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}