Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT00834535
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2009-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cefdinir Capsules 300 mg, Non-fasting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077525', 'term': 'Cefdinir'}], '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': {'email': 'clinicaltrialqueries@tevausa.com', 'phone': '1-866-384-5525', 'title': 'Manager, Biopharmaceutics', 'organization': 'TEVA Pharmaceuticals USA'}, 'certainAgreement': {'otherDetails': 'The 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': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cefdinir (Test)', 'description': '300 mg Cefdinir Capsules test product dosed in either period.'}, {'id': 'OG001', 'title': 'Omnicef® (Reference)', 'description': '300 mg Omnicef® Capsules reference product dosed in either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2081.37', 'spread': '537.12', 'groupId': 'OG000'}, {'value': '2045.43', 'spread': '481.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the T/R geometric mean x 100', 'ciPctValue': '90', 'paramValue': '100.83', 'ciLowerLimit': '93.98', 'ciUpperLimit': '108.17', 'estimateComment': 'Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\\<0.05).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over a 14 hour period.', 'description': 'Bioequivalence based on Cmax.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that completed the study had their samples analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cefdinir (Test)', 'description': '300 mg Cefdinir Capsules test product dosed in either period.'}, {'id': 'OG001', 'title': 'Omnicef® (Reference)', 'description': '300 mg Omnicef® Capsules reference product dosed in either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '10700.97', 'spread': '2328.12', 'groupId': 'OG000'}, {'value': '11121.51', 'spread': '2215.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the T/R geometric mean x 100', 'ciPctValue': '90', 'paramValue': '96.1', 'ciLowerLimit': '92.14', 'ciUpperLimit': '100.22', 'estimateComment': 'Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\\<0.05).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over a 14 hour period.', 'description': 'Bioequivalence based on AUC0-t.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that completed the study had their samples analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cefdinir (Test)', 'description': '300 mg Cefdinir Capsules test product dosed in either period.'}, {'id': 'OG001', 'title': 'Omnicef® (Reference)', 'description': '300 mg Omnicef® Capsules reference product dosed in either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '11219.51', 'spread': '2304.28', 'groupId': 'OG000'}, {'value': '11560.85', 'spread': '2237.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the T/R geometric mean x 100', 'ciPctValue': '90', 'paramValue': '96.57', 'ciLowerLimit': '92.8', 'ciUpperLimit': '100.49', 'estimateComment': 'Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\\<0.05).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over a 14 hour period.', 'description': 'Bioequivalence based on AUC0-inf.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that completed the study had their samples analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cefdinir (Test) First', 'description': '300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.'}, {'id': 'FG001', 'title': 'Omnicef® (Reference) First', 'description': '300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout of 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cefdinir (Test) First', 'description': '300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.'}, {'id': 'BG001', 'title': 'Omnicef® (Reference) First', 'description': '300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the 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': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', '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': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', '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': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2009-01-30', 'resultsFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-01-30', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-06-18', 'studyFirstPostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (Maximum Observed Concentration)', 'timeFrame': 'Blood samples collected over a 14 hour period.', 'description': 'Bioequivalence based on Cmax.'}, {'measure': 'AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)', 'timeFrame': 'Blood samples collected over a 14 hour period.', 'description': 'Bioequivalence based on AUC0-t.'}, {'measure': 'AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)', 'timeFrame': 'Blood samples collected over a 14 hour period.', 'description': 'Bioequivalence based on AUC0-inf.'}]}, '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 300 mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of OMNICEF® Capsules by CEPH International Corporation for Abbott Laboratories following a single oral dose (1 x 300mg capsule) in healthy adult subjects administered 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\n* Screening Demographics: All subjects selected for this study will be healthy men and women 18 years of age or older at the time of dosing. the subject's body mass index (BMI) should be 19 kg/m² - 30 kg/m², inclusive.\n* Screening procedures: Each 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\n* Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;\n* Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;\n* HIV antibody and hepatitis B surface antigen and hepatitis C antibody screens;\n* Urinalysis: by dipstick; full microscopic examination if dipstick positive; and\n* Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.\n* Serum Pregnancy Screen (female subjects only)\n\nIf female and:\n\n* of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD) or abstinence; or\n* is postmenopausal for at least 1 year; or\n* is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).\n\nExclusion Criteria:\n\n* Subjects with a recent history of drug or alcohol addiction or abuse.\n* 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* Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.\n* Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody.\n* Subjects demonstrating a positive drug abuse screen when screened for this study.\n* Female subjects demonstrating a positive pregnancy screening.\n* Female subjects who are currently breastfeeding.\n* Subjects with a history of allergic response(s) to cefdinir or related drugs.\n* Subjects with a history of clinically significant allergies including drug allergies.\n* Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).\n* Subjects who currently use or report using tobacco products within 3 months of Period I dose administration.\n* Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.\n* Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.\n* Subjects who have donated serum (e.g. serumpheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate serum for four weeks after completing the study.\n* Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.\n* Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.\n* Subjects who report an intolerance of direct venipuncture.\n* Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.\n* Subjects who report having difficulty fasting or consuming standardized meals.\n* Female subjects who report using implanted or injected hormonal contraceptives (birth control) during the 6 months prior to Period I dosing.\n* Female subjects who report using oral hormonal contraceptives (birth control) during the 14 days prior to Period I dosing."}, 'identificationModule': {'nctId': 'NCT00834535', 'briefTitle': 'Cefdinir Capsules 300 mg, Non-fasting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'A Relative Bioavailability Study of 300 mg Cefdinir Capsules Under Non-fasting Conditions', 'orgStudyIdInfo': {'id': 'R04-1123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Cefdinir Capsules 300 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: OMNICEF® Capsule 300 mg']}], 'interventions': [{'name': 'Cefdinir Capsules 300 mg', 'type': 'DRUG', 'description': '1 x 300 mg, single-dose non-fasting', 'armGroupLabels': ['1']}, {'name': 'OMNICEF® Capsule 300 mg', 'type': 'DRUG', 'description': '1 x 300 mg, single-dose non-fasting', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56721', 'city': 'East Grand Forks', 'state': 'Minnesota', 'country': 'United States', 'facility': 'PRACS Institute, Ltd.', 'geoPoint': {'lat': 47.92998, 'lon': -97.02452}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'PRACS Institute, Ltd.', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}], 'overallOfficials': [{'name': 'James D. Carlson, Pharm. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PRACS Institute, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}}}}