Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-29 @ 7:35 AM
Study NCT ID:
NCT06154434
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2023-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002746', 'term': 'Chlorpromazine'}], 'ancestors': [{'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-03', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-11-23', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast', 'timeFrame': 'Up to 72 hours'}, {'measure': 'Cmax', 'timeFrame': 'Up to 72 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subject']}, 'descriptionModule': {'briefSummary': 'This clinical study is an open label, randomized, fasting condition, single-dose, two-period crossover study to compare the bioequivalence of Chlorpromazine HCl 100mg Tablets after oral administration in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n1. Healthy subjects, over the age of 19 years old\n2. Weight: At least 50.0 kg and Body mass index (BMI) between 18.0-30.0 kg/m2.\n3. All subjects should be judged normal and healthy during a pre-study medical evaluation\n\n * Subjects who has no birth or chronic disease and must be in good health as determined by physical exmination and medical tests including biochemistry, urinalysis, serology and hematology etc in serum/urine.\n4. Subject is willing to participate and to Sign written informed consent form\n5. Female subjects of childbearing age who use contraception other than hormonal contraception.\n6. Subjects who has no history of psychical disorder within the last five years\n\nMain Exclusion Criteria:\n\n1. Subjects who have a medical history specified in protocol\n2. Subjects who are expected to have the prohibited medication and activity etc. during the study period\n3. Subjects who can not comply with requirements as per protocol\n4. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy\n5. Subjects who are not suitable for the clinical trial'}, 'identificationModule': {'nctId': 'NCT06154434', 'briefTitle': 'Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Whanin Pharmaceutical Company'}, 'officialTitle': 'An Open Label, Randomized, Fasting, Single-dose, Two-period Crossover Study to Compare the Bioequivalence of Chlorpromazine HCl 100mg Tablets After Oral Administration in Healthy Subjects.', 'orgStudyIdInfo': {'id': 'DDS16-065BE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Drug: Chlorpromazine HCl 100mg Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Drug: Chlorpromazine HCl 100mg Tablets']}], 'interventions': [{'name': 'Chlorpromazine HCl 100mg Tablets', 'type': 'DRUG', 'description': 'single-dose administered after a 10-hour overnight fast.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Whan In Pharm.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'MINGYU PARK', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Whanin Pharmaceutical Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}