Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-05 @ 1:22 AM
Study NCT ID:
NCT05321732
Status:
UNKNOWN
Last Update Posted:
2022-04-11
First Post:
2022-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729921', 'term': 'Enavogliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2022-01-16', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax,ss) of DWP16001', 'timeFrame': 'Before IP administration of Day 1, Day 5, and Day 6'}, {'measure': 'Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001', 'timeFrame': 'Before IP administration of Day 1, Day 5, and Day 6'}, {'measure': 'Peak Plasma Concentration (Cmax,ss) of DWC202010', 'timeFrame': 'Before IP administration and post-dose up to 24 hours'}, {'measure': 'Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010', 'timeFrame': 'Before IP administration and post-dose up to 24 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '37593838', 'type': 'DERIVED', 'citation': 'Yoon S, Park MS, Jin BH, Shin H, Na J, Huh W, Kim CO. Pharmacokinetic and pharmacodynamic interaction of DWP16001, a sodium-glucose cotransporter-2 inhibitor, with phentermine in healthy subjects. Expert Opin Drug Metab Toxicol. 2023 Jul-Dec;19(7):479-485. doi: 10.1080/17425255.2023.2249397. Epub 2023 Aug 25.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.', 'detailedDescription': 'The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05321732', 'briefTitle': 'The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults', 'orgStudyIdInfo': {'id': 'DW_DWP306001101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention: DWP16001 A mg', 'interventionNames': ['Drug: DWP16001']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention: DWC202010 B mg', 'interventionNames': ['Drug: DWP202010']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention: DWP16001 A mg + DWC202010 B mg', 'interventionNames': ['Drug: DWP16001', 'Drug: DWP202010']}], 'interventions': [{'name': 'DWP16001', 'type': 'DRUG', 'description': 'DWP16001 A mg', 'armGroupLabels': ['Intervention: DWP16001 A mg', 'Intervention: DWP16001 A mg + DWC202010 B mg']}, {'name': 'DWP202010', 'type': 'DRUG', 'description': 'DWP202010 B mg', 'armGroupLabels': ['Intervention: DWC202010 B mg', 'Intervention: DWP16001 A mg + DWC202010 B mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}