Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-30 @ 5:25 AM
Study NCT ID:
NCT00829868
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2009-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zaleplon 10 mg Capsules Under Non-Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C085665', 'term': 'zaleplon'}]}}, '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': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zaleplon', 'description': 'Zaleplon 10 mg Capsule (test) dosed in either period'}, {'id': 'OG001', 'title': 'Sonata®', 'description': 'Sonata® 10 mg Capsule (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '18.125', 'spread': '8.267', 'groupId': 'OG000'}, {'value': '16.258', 'spread': '6.212', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciPctValue': '90', 'paramValue': '109', 'ciLowerLimit': '99.3', 'ciUpperLimit': '120', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 12 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': '2009-07'}, {'type': 'PRIMARY', 'title': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zaleplon', 'description': 'Zaleplon 10 mg Capsule (test) dosed in either period'}, {'id': 'OG001', 'title': 'Sonata®', 'description': 'Sonata® 10 mg Capsule (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '64.760', 'spread': '22.564', 'groupId': 'OG000'}, {'value': '64.926', 'spread': '21.929', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciPctValue': '90', 'paramValue': '101', 'ciLowerLimit': '97.5', 'ciUpperLimit': '106', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 12 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': '2009-07'}, {'type': 'PRIMARY', 'title': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zaleplon', 'description': 'Zaleplon 10 mg Capsule (test) dosed in either period'}, {'id': 'OG001', 'title': 'Sonata®', 'description': 'Sonata® 10 mg Capsule (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '63.466', 'spread': '21.804', 'groupId': 'OG000'}, {'value': '62.878', 'spread': '20.938', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciPctValue': '90', 'paramValue': '100', 'ciLowerLimit': '96.2', 'ciUpperLimit': '104', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 12 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': '2009-07'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zaleplon (Test) First', 'description': 'Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period'}, {'id': 'FG001', 'title': 'Sonata® (Reference) First', 'description': 'Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zaleplon (Test) First', 'description': 'Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period'}, {'id': 'BG001', 'title': 'Sonata® (Reference) First', 'description': 'Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (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': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', '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': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Biracial', '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': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', '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': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2009-01-26', 'resultsFirstSubmitDate': '2009-07-06', 'studyFirstSubmitQcDate': '2009-01-26', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-07-06', 'studyFirstPostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Concentration', 'timeFrame': 'Blood samples collected over 12 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 12 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 (Per Participant)', 'timeFrame': 'Blood samples collected over 12 hour period', 'description': 'Bioequivalence based on AUC0-t'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, 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\n* non-smokers\n* at least 18 years of age\n* subjects will have a BMI (body mass index) of 30 or less\n\nExclusion Criteria:\n\n* Subjects with a significant recent history of chronic alcohol consumption(past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma(past 5 years), diabetes,psychosis or glaucoma will not be eligible for this study.\n* Subjects whose clinical laboratory test values are outside the reference range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range of retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.\n* Subjects who have history of allergic responses to the class of drug being tested will be excluded from the study. Subjects with intolerance to alcohol or or other CNS depressants should not participate in this study.\n* Subjects whou use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.\n* All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.\n* Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.\n* Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.\n* Female subjects who are pregnant , breast feeding, or whi are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) of they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 14 days of dosing or implanted or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.\n* All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive of inconclusive results will be withdrawn from the study.\n* Subjects who do not tolerate venipuncture will not be allowed to participate.'}, 'identificationModule': {'nctId': 'NCT00829868', 'briefTitle': 'Zaleplon 10 mg Capsules Under Non-Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'A Relative Bioavailability Study of Zaleplon 10 mg Capsules Under Non-Fasting Conditions', 'orgStudyIdInfo': {'id': 'B046502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zaleplon', 'description': 'Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period', 'interventionNames': ['Drug: Zaleplon 10 mg Capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sonata®', 'description': 'Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period', 'interventionNames': ['Drug: SONATA® 10 mg capsules']}], 'interventions': [{'name': 'Zaleplon 10 mg Capsules', 'type': 'DRUG', 'description': '1 x 10 mg', 'armGroupLabels': ['Zaleplon']}, {'name': 'SONATA® 10 mg capsules', 'type': 'DRUG', 'description': '1 x 10 mg', 'armGroupLabels': ['Sonata®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77042-4712', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Novum Pharmaceutical Research Services', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'So Ran Hong, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novum Pharmaceuticals Research Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}}}}