Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-29 @ 6:08 AM
Study NCT ID:
NCT05465668
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2022-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of DWP16001 Drug A and C
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': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2022-07-05', 'studyFirstSubmitQcDate': '2022-07-19', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax,ss of DWP16001', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0.25 to 72 hour.', 'description': 'Peak Plasma Concetration of DWP16001'}, {'measure': 'AUClast of DWP16001', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0.25 to 72 hour.', 'description': 'The area under the plasma drug concentration-time curve of DWP16001'}], 'secondaryOutcomes': [{'measure': 'Tmax of DWP16001', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0.25 to 72 hour.', 'description': 'Time at Cmax of DWP16001'}, {'measure': 'T1/2 of DWP16001', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0.25 to 72 hour.', 'description': 'Half life of DWP16001'}, {'measure': 'CL/F of DWP16001', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0.25 to 72 hour.', 'description': 'Apparent total clearance of the drug from plasma after oral administration of DWP16001'}, {'measure': 'Vd/F of DWP16001', 'timeFrame': 'At pre-dose (0 hour), and post-dose 0.25 to 72 hour.', 'description': 'Volume of distribution of DWP16001'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.', 'detailedDescription': 'The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2\n\n☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2\n\nExclusion Criteria:\n\n* musculoskeletal diseases\n* mental diseases\n* hemato-oncologic diseases'}, 'identificationModule': {'nctId': 'NCT05465668', 'briefTitle': 'Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of DWP16001 Drug A and C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug C in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWP16001106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention: DWP16001 Drug A', 'description': '1 tablet, Oral, once daily single dose', 'interventionNames': ['Drug: DWP16001 Drug A']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention: DWP16001 Drug C', 'description': '1 tablet, Oral, once daily single dose', 'interventionNames': ['Drug: DWP16001 Drug C']}], 'interventions': [{'name': 'DWP16001 Drug A', 'type': 'DRUG', 'description': 'DWP16001 Drug A', 'armGroupLabels': ['Intervention: DWP16001 Drug A']}, {'name': 'DWP16001 Drug C', 'type': 'DRUG', 'description': 'DWP16001 Drug C', 'armGroupLabels': ['Intervention: DWP16001 Drug C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam', 'country': 'South Korea', 'facility': 'CHA unuversity bundang medical center', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}