Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT01045967
Status:
COMPLETED
Last Update Posted:
2010-12-08
First Post:
2010-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lansoprazole 30 mg DR Capsule Fasting Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064747', 'term': 'Lansoprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.', 'description': 'Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.', 'eventGroups': [{'id': 'EG000', 'title': 'Test (Lansoprazole)', 'description': '30 mg Lansoprazole DR Capsules test product dosed in either period.', 'otherNumAtRisk': 56, 'otherNumAffected': 6, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference (Prevacid®)', 'description': '30 mg Prevacid® DR Capsules reference product dosed in either period.', 'otherNumAtRisk': 56, 'otherNumAffected': 3, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'notes': 'Light Headed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax (Maximum Observed Concentration of Drug Substance in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Lansoprazole)', 'description': '30 mg Lansoprazole DR Capsules test product dosed in either period.'}, {'id': 'OG001', 'title': 'Reference (Prevacid®)', 'description': '30 mg Prevacid® DR Capsules reference product dosed in either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '939.025', 'spread': '438.28', 'groupId': 'OG000'}, {'value': '865.678', 'spread': '359.365', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the T/R geometric mean x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105', 'ciLowerLimit': '90.7', 'ciUpperLimit': '122', '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', 'testedNonInferiority': True, 'nonInferiorityComment': 'ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \\[T\\]/Reference\\[R\\]) of the identified metrics (e.g. AUC, Cmax).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over a 12 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': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Lansoprazole)', 'description': '30 mg Lansoprazole DR Capsules test product dosed in either period.'}, {'id': 'OG001', 'title': 'Reference (Prevacid®)', 'description': '30 mg Prevacid® DR Capsules reference product dosed in either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2156.104', 'spread': '1746.337', 'groupId': 'OG000'}, {'value': '2130.082', 'spread': '1486.442', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the T/R geometric mean x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.2', 'ciLowerLimit': '86.1', 'ciUpperLimit': '110', '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', 'testedNonInferiority': True, 'nonInferiorityComment': 'ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \\[T\\]/Reference\\[R\\]) of the identified metrics (e.g. AUC, Cmax).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over a 12 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': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Lansoprazole)', 'description': '30 mg Lansoprazole DR Capsules test product dosed in either period.'}, {'id': 'OG001', 'title': 'Reference (Prevacid®)', 'description': '30 mg Prevacid® DR Capsules reference product dosed in either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2253.776', 'spread': '2126.251', 'groupId': 'OG000'}, {'value': '2195.918', 'spread': '1667.722', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the T/R geometric mean x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.4', 'ciLowerLimit': '86.3', 'ciUpperLimit': '110', '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', 'testedNonInferiority': True, 'nonInferiorityComment': 'ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \\[T\\]/Reference\\[R\\]) of the identified metrics (e.g. AUC, Cmax).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over a 12 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': 'Test (Lansoprazole) First', 'description': '30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.'}, {'id': 'FG001', 'title': 'Reference (Prevacid®) First', 'description': '30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout of 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'comment': 'Subject was dropped prior to dosing in Period II due to positive drug screen.', 'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test (Lansoprazole) First', 'description': '30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.'}, {'id': 'BG001', 'title': 'Reference (Prevacid®) First', 'description': '30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR 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': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', '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': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', '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': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-22', 'studyFirstSubmitDate': '2010-01-08', 'resultsFirstSubmitDate': '2010-02-22', 'studyFirstSubmitQcDate': '2010-01-08', 'lastUpdatePostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-22', 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (Maximum Observed Concentration of Drug Substance in Plasma)', 'timeFrame': 'Blood samples collected over a 12 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 12 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 12 hour period.', 'description': 'Bioequivalence based on AUC0-inf.'}]}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under 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 or light smokers (10 or less cigarettes per day)\n* 18 years of age or older\n* Body Mass Index of 30 or less\n* Males or non-pregnant females\n* Normal clinical laboratory test results\n\nExclusion Criteria:\n\n* Subjects with a significant 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 the study.\n* Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on 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 a history of allergic responses to the class of drug being tested will be excluded from the study.\n* Subjects who are heavy users of tobacco (smoke more than 10 cigarettes a day, smoke cigars or pipes, or use oral tobacco products) will not be eligible to participate in the study. Light smokers may participate, but can not smoke from 2 hours before dosing until 2 hours after dosing.\n* 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 30 days prior to the first dosing of the study.\n* Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allow 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) or they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 180 days of dosing will not be allowed to participate.\n* Female subjects with a positive or inconclusive pregnancy test result will be withdrawn from the study.\n* Subjects who do not tolerate venipuncture will not be allowed to participate.'}, 'identificationModule': {'nctId': 'NCT01045967', 'briefTitle': 'Lansoprazole 30 mg DR Capsule Fasting Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'A Relative Bioavailability Study of Lansoprazole 30 mg DR Capsules Under Fasting Conditions.', 'orgStudyIdInfo': {'id': 'B046530'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Invesigational Test Product', 'description': 'Lansoprazole 30 mg delayed-release Capsules', 'interventionNames': ['Drug: Lansoprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Listed Drug', 'description': 'Prevacid® 30 mg delayed-release Capsules', 'interventionNames': ['Drug: Prevacid®']}], 'interventions': [{'name': 'Lansoprazole', 'type': 'DRUG', 'description': '30 mg delayed-release Capsule', 'armGroupLabels': ['Invesigational Test Product']}, {'name': 'Prevacid®', 'type': 'DRUG', 'otherNames': ['Lansoprazole (generic name)'], 'description': '30 mg delayed-release Capsule', 'armGroupLabels': ['Reference Listed Drug']}]}, 'contactsLocationsModule': {'locations': [{'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'}}}}