Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT06307132
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excretion volume', 'timeFrame': 'Within 12 hours after taking medication', 'description': 'drug concentration in urine'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bioequivalence Trial']}, 'descriptionModule': {'briefSummary': 'This project will be based on the bioequivalence test of Aximus capsules, measuring the body composition indicators of healthy subjects before and after medication, and collecting urine samples from subjects at different time periods after medication, measuring urine drug concentration, calculating urine excretion, analyzing the individualized differences in metabolism and excretion of Aximus capsules under different health states of human components, and providing guidance for clinical precision medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult men and non-pregnant non-lactating women who successfully participated in the bioequivalence test of acylimus capsules；\n2. Signed the informed consent form, and fully understood the content, process and risks of this research, and be able to communicate well with the researchers.\n\nExclusion Criteria:\n\n1. Female subjects who are menstruating (which may affect urine sample collection);\n2. The subjects may not be able to complete this study for other reasons or may not be suitable to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06307132', 'briefTitle': 'Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'A Study on the Correlation of Drug Metabolism, Excretion, and Human Body Composition Based on the Bioequivalence Trial of Aximus Capsules', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2024-03-106'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'test preparation', 'interventionNames': ['Other: Aximus capsules（test）']}, {'label': 'reference preparation', 'interventionNames': ['Drug: Aximus capsules（reference）']}], 'interventions': [{'name': 'Aximus capsules（test）', 'type': 'OTHER', 'description': 'Aximus capsules test preparation', 'armGroupLabels': ['test preparation']}, {'name': 'Aximus capsules（reference）', 'type': 'DRUG', 'description': 'Aximus capsules reference preparation', 'armGroupLabels': ['reference preparation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wenzhou', 'country': 'China', 'facility': 'The Second Affiliated Hospital of WMU Phase l Clinical Trial Unit /Center Of Bioequivalence Study', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Ting Li, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Wenzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'TING LI', 'investigatorAffiliation': 'Second Affiliated Hospital of Wenzhou Medical University'}}}}