Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-27 @ 12:53 PM
Study NCT ID:
NCT05532332
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2022-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Fluoxetine in Healthy Adult Subjects Under Fasting Condition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2022-09-04', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': '(Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours', 'description': 'Cmax is observed as the maximum of Fluoxetine peak concentration'}, {'measure': 'Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h)', 'timeFrame': '(Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours', 'description': 'The AUC (0-72h) is the area under the Fluoxetine plasma concentration with time curve from the time of dosing to the 72-hour sample'}], 'secondaryOutcomes': [{'measure': 'Maximum time (Tmax)', 'timeFrame': '(Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours', 'description': 'Time until Cmax is reached'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Randomized', 'Crossover', 'Fluoxetine'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each Fluoxetine 10 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.', 'detailedDescription': 'Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 21 days.\n\nFluoxetine plasma concentrations were determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent is obtained for the study.\n* Age 18 - 55 years\n* Body mass index between 18.5 and 30 kg/m2\n* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.\n* Vital signs without significant deviations.\n* All laboratory screening results are within the normal range or clinically non-significant\n\nExclusion Criteria:\n\n* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk, or interfere with the ability of the subject to complete the study in the investigator's opinion.\n* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.\n* Any confirmed significant allergic reactions against any drug or multiple allergies.\n* Clinically significant illness 28 days before study phase I.\n* Alcohol or any solvent intake.\n* Regular use of medication.\n* Positive urine screening of drugs of abuse.\n* Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.\n* History or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.\n* Blood donation within the past 60 days.\n* Participation in another bioequivalence study within 60 days prior to the start of phase I of the study."}, 'identificationModule': {'nctId': 'NCT05532332', 'briefTitle': 'Bioequivalence Study of Fluoxetine in Healthy Adult Subjects Under Fasting Condition', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'A Randomized, Single Oral Dose, Two-way Crossover, Open-label, Laboratory Blind, Bioequivalence Study Comparing Fluoxetine From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'ALZ-B-20-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Product (T)', 'description': 'subjects were administered a single hard gelatin capsule of 10 mg Fluoxetine with approximately 240 ml water after an overnight fast of 10 hours', 'interventionNames': ['Drug: Fluoxetine 10 mg capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Product (R)', 'description': 'subjects were administered a single hard gelatin capsule of 10 mg Fluoxetine with approximately 240 ml water after an overnight fast of 10 hours', 'interventionNames': ['Drug: Prozac® 10 mg capsules']}], 'interventions': [{'name': 'Fluoxetine 10 mg capsules', 'type': 'DRUG', 'otherNames': ['Test product (T)'], 'description': 'an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg', 'armGroupLabels': ['Test Product (T)']}, {'name': 'Prozac® 10 mg capsules', 'type': 'DRUG', 'otherNames': ['Reference product (R)'], 'description': 'an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg', 'armGroupLabels': ['Reference Product (R)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11835', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Future Research Center (FRC)', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Hala Masoud, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Future Research Center (FRC)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 months following article publication and no end date', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Researchers who provide a methodologically sound proposal. Proposals should be directed to \\<hala.fut.masoud@gmail.com\\> To gain access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'FRC Technical Director & CEO', 'investigatorFullName': 'Hala Masoud', 'investigatorAffiliation': 'Future University in Egypt'}}}}