Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 9:07 PM
Study NCT ID:
NCT04961905
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2021-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Characteristics and Safety After Administration of NVP-2002
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': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-07-04', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of plasma: Cmax', 'timeFrame': '0hours - 72hours', 'description': 'Cmax of NVP-2002-R1 and NVP-2002-R2'}, {'measure': 'Pharmacokinetics of plasma: AUCt', 'timeFrame': '0hours - 72hours', 'description': 'Area under the curve of NVP-2002-R1 and NVP-2002-R2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers.', 'detailedDescription': 'Phase 1 to evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2. Which is designed as ramdomized, oral, single dose, 2×2 crossover.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy adult subjects who signed informed consent\n* Body Mass Index(BMI)=18.5\\~29.9kg/㎡\n\nExclusion Criteria:\n\n* Subjects participated in another clinical trial within 6 months prior to administration of the study drug\n* Inadequate subject for the clinical trial by the investigator's decision\n* Upper Limits of Normal x 1.5 \\< Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin"}, 'identificationModule': {'nctId': 'NCT04961905', 'briefTitle': 'Pharmacokinetic Characteristics and Safety After Administration of NVP-2002', 'organization': {'class': 'INDUSTRY', 'fullName': 'NVP Healthcare'}, 'officialTitle': 'A Phase I Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and Safety After Administration of NVP-2002 and Co-administration of NVP-2002-R1 and NVP-2002-R2 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'NVP-2002_BA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single tablet fist, fasted', 'description': 'single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition', 'interventionNames': ['Drug: NVP-2002-R1+NVP-2002-R2']}, {'type': 'EXPERIMENTAL', 'label': 'FDC fist, fasted', 'description': 'NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition', 'interventionNames': ['Drug: NVP-2002']}, {'type': 'EXPERIMENTAL', 'label': 'Single tablet fist, fed', 'description': 'single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition', 'interventionNames': ['Drug: NVP-2002-R1+NVP-2002-R2']}, {'type': 'EXPERIMENTAL', 'label': 'FDC fist, fed', 'description': 'NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition', 'interventionNames': ['Drug: NVP-2002']}], 'interventions': [{'name': 'NVP-2002-R1+NVP-2002-R2', 'type': 'DRUG', 'description': 'NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily', 'armGroupLabels': ['Single tablet fist, fasted', 'Single tablet fist, fed']}, {'name': 'NVP-2002', 'type': 'DRUG', 'description': 'NVP-2002 is a combination of NVP-2002-R1 and NVP-2002\\_R2 NVP-2002, 1 tablet, once daily', 'armGroupLabels': ['FDC fist, fasted', 'FDC fist, fed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54907', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Jeonbuk national university hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'overallOfficials': [{'name': 'Min-Gul Kim, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jeonbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NVP Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}