Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT00836706
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2009-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clarithromycin 500 mg Tablets Under Non-Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialqueries@tevausa.com', 'phone': '1-866-384-5525', 'title': 'Manager, Biopharmaceutics', 'organization': 'Teva Pharmaceuticals USA'}, 'certainAgreement': {'otherDetails': 'Principal Investigator is not permitted to discuss or publish trial results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax - Maximum Observed Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin', 'description': 'Clarithromycin 500 mg Tablets (test) dosed in either period'}, {'id': 'OG001', 'title': 'Biaxin®', 'description': 'Biaxin® 500 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '2440.545', 'spread': '764.773', 'groupId': 'OG000'}, {'value': '2414.955', 'spread': '859.636', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test/Ref Ratio of LS Means x 100', 'ciPctValue': '90', 'paramValue': '101', 'ciLowerLimit': '85.2', 'ciUpperLimit': '120', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on Cmax', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}, {'type': 'PRIMARY', 'title': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin', 'description': 'Clarithromycin 500 mg Tablets (test) dosed in either period'}, {'id': 'OG001', 'title': 'Biaxin®', 'description': 'Biaxin® 500 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '13509.616', 'spread': '4764.228', 'groupId': 'OG000'}, {'value': '13278.682', 'spread': '4643.690', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test/Ref Ratio of LS Means x 100', 'ciPctValue': '90', 'paramValue': '101', 'ciLowerLimit': '88.7', 'ciUpperLimit': '114', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on AUC0-inf', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}, {'type': 'PRIMARY', 'title': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin', 'description': 'Clarithromycin 500 mg Tablets (test) dosed in either period'}, {'id': 'OG001', 'title': 'Biaxin®', 'description': 'Biaxin® 500 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '13424.597', 'spread': '4778.315', 'groupId': 'OG000'}, {'value': '13192.468', 'spread': '4606.320', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test/Ref Ratio of LS Means x 100', 'ciPctValue': '90', 'paramValue': '101', 'ciLowerLimit': '88.4', 'ciUpperLimit': '114', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on AUC0-t', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clarithromycin (Test) First', 'description': 'Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.'}, {'id': 'FG001', 'title': 'Biaxin® (Reference) First', 'description': 'Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout: 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clarithromycin (Test) First', 'description': 'Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.'}, {'id': 'BG001', 'title': 'Biaxin® (Reference) First', 'description': 'Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2002-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2009-02-02', 'resultsFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-02-02', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-06-18', 'studyFirstPostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Concentration', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on Cmax'}, {'measure': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on AUC0-inf'}, {'measure': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration', 'timeFrame': 'Blood samples collected over 48 hour period', 'description': 'Bioequivalence based on AUC0-t'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects under non-fasting conditions.', 'detailedDescription': 'Criteria for Evaluation: FDA Bioequivalence Criteria\n\nStatistical Methods: FDA bioequivalence statistical methods'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.\n\nEach subject will complete the screening process within 28 days prior to period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.\n\nScreening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.\n\nThe screening clinical laboratory procedures will include:\n\nHEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase HIV antibody, hepatitis B surface antigen, hepatitis C antibody screens URINALYSIS: by dipstick; full microscopic examination if dipstick positive URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine SERUM PREGNANCY SCREEN (female subjects only) FOLLICLE STIMULATING HORMONE (FSH; female subjects only): verify postmenopausal status\n\nIf female and :\n\nis postmenopausal for at least 1 year; or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).\n\nExclusion Criteria:\n\nSubjects with a recent history of drug or alcohol addiction or abuse. Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).\n\nSubjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.\n\nSubjects demonstration a positive hepatitis B surface antigen screen, hepatitis C antibody screen or a reactive HIV antibody screen.\n\nSubjects demonstrating a positive drug abuse screen when screened for this study.\n\nFemale subjects who are currently breast feeding. Female subjects who are demonstrating a positive pregnancy screen. Subjects with a history of allergic response(s) to Clarithromycin or related drugs.\n\nSubjects with a history of clinically significant allergies including drug allergies.\n\nSubjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).\n\nSubjects who currently use or reports using tobacco or nicotine-containing products within 90 days prior to Period I dosing.\n\nSubjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.\n\nSubjects who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will by advised not to donate blood for four weeks after completing the study.\n\nSubjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.\n\nSubjects who report receiving any investigational drug within 30 days prior to Period I dosing.\n\nSubjects who report taking any prescription medication in the 14 days prior to Period I dosing, with the exception of topical products without systemic absorption.\n\nSubjects who have been on an abnormal diet during the 28 days prior to Period I dosing.\n\nSubjects who report an intolerance of direct venipuncture."}, 'identificationModule': {'nctId': 'NCT00836706', 'briefTitle': 'Clarithromycin 500 mg Tablets Under Non-Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'A Relative Bioavailability Study of 500 mg Clarithromycin Tablets Under Non-Fasting Conditions', 'orgStudyIdInfo': {'id': 'R02-664'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clarithromycin (test)', 'description': 'Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period', 'interventionNames': ['Drug: clarithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biaxin®', 'description': 'Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period', 'interventionNames': ['Drug: BIAXIN®']}], 'interventions': [{'name': 'clarithromycin', 'type': 'DRUG', 'description': '500 mg Tablet', 'armGroupLabels': ['Clarithromycin (test)']}, {'name': 'BIAXIN®', 'type': 'DRUG', 'description': '500 mg Tablet', 'armGroupLabels': ['Biaxin®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56721', 'city': 'East Grand Forks', 'state': 'Minnesota', 'country': 'United States', 'facility': 'PRACS Institute, Ltd.', 'geoPoint': {'lat': 47.92998, 'lon': -97.02452}}], 'overallOfficials': [{'name': 'James D Carlson, Pharm. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PRACS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}}}}