Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT02123459
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2014-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Cephalexin Suspension in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cephalexin (Reference)', 'description': 'Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods\n\nCephalexin: Administered orally', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cephalexin (Test)', 'description': 'Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods\n\nCephalexin: Administered orally', 'otherNumAtRisk': 28, 'otherNumAffected': 2, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cephalexin (Reference)', 'description': 'Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods'}, {'id': 'OG001', 'title': 'Cephalexin (Test)', 'description': 'Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods'}], 'classes': [{'categories': [{'measurements': [{'value': '29.539', 'spread': '22.919', 'groupId': 'OG000'}, {'value': '35.857', 'spread': '14.452', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period', 'unitOfMeasure': 'Hours*microgram per milliliter(h*μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cephalexin (Reference)', 'description': 'Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods'}, {'id': 'OG001', 'title': 'Cephalexin (Test)', 'description': 'Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods'}], 'classes': [{'categories': [{'measurements': [{'value': '10.378', 'spread': '25.616', 'groupId': 'OG000'}, {'value': '12.610', 'spread': '23.867', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cephalexin (Reference)', 'description': 'Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods'}, {'id': 'OG001', 'title': 'Cephalexin (Test)', 'description': 'Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods'}], 'classes': [{'categories': [{'measurements': [{'value': '1.500', 'spread': '0.881', 'groupId': 'OG000'}, {'value': '1.500', 'spread': '0.758', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cephalexin Dosing Sequence AB', 'description': 'Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).There was an interval of 1 day between doses.'}, {'id': 'FG001', 'title': 'Cephalexin Dosing Sequence BA', 'description': 'Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).There was an interval of 1 day between doses.'}], 'periods': [{'title': 'Period 1 (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '9.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-08', 'studyFirstSubmitDate': '2014-04-23', 'resultsFirstSubmitDate': '2015-05-08', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-08', 'studyFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose', 'timeFrame': 'Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin', 'timeFrame': 'Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period'}, {'measure': 'Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum', 'timeFrame': 'Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. The study is expected to last about 2 days for each participant, not including screening or follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation will be voluntary.\n* The body mass index of participants should be between 18-27.\n* Participants should have a good health status.\n* Limits of variation allowed within normal values at screening will be: blood pressure (seated) up to 139 millimeters of mercury (mm Hg), for systolic, and up to 89 mm Hg for diastolic; heart rate between 60 and 100 beats per minute, and respiratory rate between 14 and 20 breaths per minute.\n* Hepatitis B and C and human immunodeficiency virus (HIV) negative.\n* Drug abuse or alcohol detection test approximately 12 hours before administering the study medication.\n* Serum pregnancy test (beta human chorionic gonadotropin) at screening and urine pregnancy test approximately 12 hours before administering the study medication.\n\nExclusion Criteria:\n\n* Participants with any clinically significant abnormality in their vital sign constants recorded at screening.\n* Sponsor´s and/or site employees.\n* Abnormal 12 lead electrocardiogram (ECG) that in the opinion of the investigator places the participant at an unacceptable risk for study participation, Bazett corrected QR interval (QTcB) \\> 470 millisecond (msec) for women and \\> 450 msec for men.\n* Participants with history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal diseases, including constipation, neurological, endocrine, hematopoietic diseases, or any type of anemia, asthma, mental disease, or other organic abnormalities.\n* Participants with a creatinine clearance \\< 80 mL/min based on the Cockcroft-Gault equation.\n* Participants requiring any medication during the study, apart from the medication which is being studied.\n* Participants with history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer.\n* Participants who have been exposed to medications known as hepatic enzyme inducers or inhibitors or who have been taking potentially toxic medications within the 30 days prior.\n* Participants who have received any medication, including vitamins (with or without medical prescription) or herbal-based remedies 30 days (or 7 half-lives) prior to the beginning of the study.\n* Participants who have been hospitalized for any condition within six months to the beginning of the study.\n* Participants who have received investigational drugs within the 60 days prior to the study.\n* Participants allergic to any medication, food, or substance.\n* Participants who require therapy with nephrotoxic drugs.\n* Participants who have donated 450 mL of blood or more within the 60 days prior to the beginning of the study.\n* Participants with history of drug and alcohol abuse.\n* Participants with special diet requirement for any cause.\n* Participants with positive to pregnancy test or are breastfeeding.\n* Participants on hormonal treatment by any route.\n* Participants who have not been recorded in the page of the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS).'}, 'identificationModule': {'nctId': 'NCT02123459', 'briefTitle': 'A Study of Cephalexin Suspension in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Open-label, Two-period, Two-treatment, Two-sequence, Crossover Study to Evaluate the Bioequivalence of Single Doses of Two Oral Preparations in Suspension With 250 mg/5 ml of Cephalexin (Keflex® Liquido Made in Mexico by Eli Lilly y Compañía de México, S.A. de C.V. vs. Keflex® Liquido Made by Antibioticos do Brasil Ltda for Eli Lilly y Compañía de México, S.A. de C.V.) in Fasting Healthy Volunteers', 'orgStudyIdInfo': {'id': '15314'}, 'secondaryIdInfos': [{'id': 'A3Q-ME-AFBQ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cephalexin (Reference)', 'description': 'Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods', 'interventionNames': ['Drug: Cephalexin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cephalexin (Test)', 'description': 'Cephalexin manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods', 'interventionNames': ['Drug: Cephalexin']}], 'interventions': [{'name': 'Cephalexin', 'type': 'DRUG', 'otherNames': ['Keflex®'], 'description': 'Administered orally', 'armGroupLabels': ['Cephalexin (Reference)', 'Cephalexin (Test)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14610', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}