Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-04-13 @ 3:43 PM
Study NCT ID:
NCT01767532
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2013-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Cephalexin Suspension 125
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002506', 'term': 'Cephalexin'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'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': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2011-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-21', 'studyFirstSubmitDate': '2013-01-10', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (CMAX) of cephalexin', 'timeFrame': '0.0, 0.083, 0.167, 0.333, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 postdosage', 'description': 'Pharmacokinetics'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of cephalexin', 'timeFrame': '0.0, 0.083, 0.167, 0.333, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 postdosage', 'description': 'Pharmacokinetics'}]}, 'conditionsModule': {'keywords': ['Cephalexin', 'Respiratory infections', 'Mexico', 'Bioequivalence'], 'conditions': ['Infections, Respiratory Tract']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gsk-clinicalstudyregister.com/study/116990?search=study&search_terms=116990#rs', 'label': 'Results for study 116990 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent.\n\nTest product was Ceporex® (125 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 20 ml of suspension.\n\nThe study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.\n\nThe population was composed of 28 healthy volunteers, both genders, adults between 18-50 years.\n\nThe comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFree will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.\n\nHealthy, between 18 and 50 years. Body Mass Index between 18 and 27.5 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.\n\nLaboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -\n\nExclusion Criteria:\n\nAlteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.\n\nRequirement of any kind of medication during the course of the study, except study medication.\n\nHistory of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.\n\nAdministration of any medication in the 7 half-lives previous to the beginning of the study.\n\nHospitalization for any cause in the two months before the beginning of the study.\n\nAdministration of investigational drugs in the 60 days before the study. Allergy to any medication, food or substance. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.\n\nBlood donation or loss =\\> 450 ml in the 60 days before the beginning of the study.\n\nHistory of drug or alcohol abuse. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Positive antidoping or pregnancy test Breast-feeding. Females on hormonal treatment.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01767532', 'briefTitle': 'Bioequivalence Study of Cephalexin Suspension 125', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparation of Cephalexin 125 mg/ 5 ml (Ceporex® GlaxoSmithKline México, S.A. de C.V. vs. Keflex®, Eli Lilly y Compañía de México, S.A. de C.V.) in Fasting Healthy Volunteers', 'orgStudyIdInfo': {'id': '116990'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A(reference)/B(test)', 'description': 'initial administration of reference and cross-over to test', 'interventionNames': ['Drug: Cephalexin 125 mg/5ml']}, {'type': 'EXPERIMENTAL', 'label': 'B(test)/A(reference)', 'description': 'initial administration of test and cross-over to reference', 'interventionNames': ['Drug: Cephalexin 125 mg/5ml']}], 'interventions': [{'name': 'Cephalexin 125 mg/5ml', 'type': 'DRUG', 'otherNames': ['Keflex® suspension ELI LILLY Y COMPAÑIA DE MEXICO SA de CV'], 'description': 'Reference product 20 ml', 'armGroupLabels': ['A(reference)/B(test)', 'B(test)/A(reference)']}, {'name': 'Cephalexin 125 mg/5ml', 'type': 'DRUG', 'otherNames': ['Ceporex® granulate for suspension GLAXOSMITHKLINE MEXICO SA de CV'], 'description': 'Test product 20 ml', 'armGroupLabels': ['A(reference)/B(test)', 'B(test)/A(reference)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}