Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT05532267
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2022-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Ciprofloxacin in Healthy Adult Subjects Under Fasting Condition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-11-13', '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': '2020-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum blood concentration (Cmax)', 'timeFrame': 'Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration', 'description': 'Cmax is observed as the maximum of ciprofloxacin peak concentration'}, {'measure': 'the area under the curve (AUC 0-t)', 'timeFrame': 'Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration', 'description': 'Cumulative Area Under the ciprofloxacin plasma concentration-time Curve calculated from 0 to time of last quantifiable concentration (t last) using the Trapezoidal method'}, {'measure': 'the area under the curve extrapolated to infinity (AUC0-∞)', 'timeFrame': 'Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration', 'description': 'AUC from Dosing time extrapolated to infinity, based on the last observed concentration'}], 'secondaryOutcomes': [{'measure': 'Maximum time (Tmax)', 'timeFrame': 'Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration', 'description': 'Time until Cmax is reached'}, {'measure': 'Apparent terminal half-life (t½)', 'timeFrame': 'Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration', 'description': 'the time required for the ciprofloxacin plasma concentration to decrease by 50% after the pseudo-equilibrium of distribution has been reached'}, {'measure': 'Apparent elimination rate constant (Kel).', 'timeFrame': 'Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration', 'description': 'First-order rate constant associated with the terminal (log-linear) portion of the curve'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Randomized', 'Crossover', 'Ciprofloxacin'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Ciprofloxacin 750 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 7 days.\n\nCiprofloxacin 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 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 opinion of the investigator.\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': 'NCT05532267', 'briefTitle': 'Bioequivalence Study of Ciprofloxacin 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 Ciprofloxacin From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'CIP-B-20-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Product (T)', 'description': 'subjects were administered a single film-coated tablet of 750 mg Ciprofloxacin with approximately 240 ml water after an overnight fast of 10 hours', 'interventionNames': ['Drug: Ciprofloxacin 750 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Product (R)', 'description': 'subjects were administered a single film-coated tablet of 750 mg Ciprofloxacin with approximately 240 ml water after an overnight fast of 10 hours', 'interventionNames': ['Drug: Ciproxin 750 mg']}], 'interventions': [{'name': 'Ciprofloxacin 750 mg', 'type': 'DRUG', 'otherNames': ['Test product (T)'], 'description': 'an immediate release film-coated tablet containing 750 mg Ciprofloxacin', 'armGroupLabels': ['Test Product (T)']}, {'name': 'Ciproxin 750 mg', 'type': 'DRUG', 'otherNames': ['Reference product (R)'], 'description': 'an immediate release film-coated tablet containing 750 mg Ciprofloxacin', 'armGroupLabels': ['Reference Product (R)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11835', 'city': 'Cairo', 'state': 'New 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'}}}}