Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:40 PM
Study NCT ID:
NCT03472651
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2018-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study to Compare Two Formulations of Deanxit®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000851', 'term': 'flupentixol, melitracen drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-03-14', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-72h: flupentixol', 'timeFrame': 'from zero to 72 hours post-dose', 'description': 'the area under the flupentixol plasma concentration-time curve'}, {'measure': 'Cmax: flupentixol', 'timeFrame': 'from zero to 72 hours post-dose', 'description': 'maximum observed plasma concentration of flupentixol'}, {'measure': 'AUC0-72h: melitracen', 'timeFrame': 'from zero to 72 hours post-dose', 'description': 'the area under the melitracen plasma concentration-time curve'}, {'measure': 'Cmax: melitracen', 'timeFrame': 'from zero to 72 hours post-dose', 'description': 'maximum observed concentration of melitracen'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed condition'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 28 kg/m2.\n* Women must be non-pregnant and non-lactating'}, 'identificationModule': {'nctId': 'NCT03472651', 'briefTitle': 'Bioequivalence Study to Compare Two Formulations of Deanxit®', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Randomized, Single Dose, Open-label, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®) - in Fasted and Fed Conditions', 'orgStudyIdInfo': {'id': '17686A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A1 Fasted condition', 'description': 'Subjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort', 'interventionNames': ['Drug: test treatment: flupentixol/melitracen', 'Drug: reference treatment: flupentixol/melitracen']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A2 Fed condition', 'description': 'Subjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort', 'interventionNames': ['Drug: test treatment: flupentixol/melitracen', 'Drug: reference treatment: flupentixol/melitracen']}], 'interventions': [{'name': 'test treatment: flupentixol/melitracen', 'type': 'DRUG', 'description': '0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose', 'armGroupLabels': ['Cohort A1 Fasted condition', 'Cohort A2 Fed condition']}, {'name': 'reference treatment: flupentixol/melitracen', 'type': 'DRUG', 'otherNames': ['Deanxit®'], 'description': '0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose', 'armGroupLabels': ['Cohort A1 Fasted condition', 'Cohort A2 Fed condition']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'CN1036 Shijitan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@Lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}