Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-03-02 @ 8:56 PM
Study NCT ID:
NCT00759759
Status:
COMPLETED
Last Update Posted:
2010-08-17
First Post:
2008-09-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
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'MVenugopal@actavis.com', 'phone': '908-659-2885', 'title': 'Meena Venugopal, Director, Clinical R&D', 'organization': 'Actavis Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Treatment A Followed by Treatment B', 'otherNumAffected': 7, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: Treatment B Followed by Treatment A', 'otherNumAffected': 10, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vasovagal Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Mood Altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Morphine Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine Sulfate 200 mg SR Capsules by Alpharma'}, {'id': 'OG001', 'title': 'KADIAN® 100mg Caps by Alpharma'}], 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '46.8', 'spread': '15.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'mean ratio', 'ciPctValue': '90', 'paramValue': '90.46', 'ciLowerLimit': '82.9', 'ciUpperLimit': '98.7', 'groupDescription': 'ANOVA of ln-transformed plasma morphine Cmax', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.'}], 'paramType': 'MEAN', 'timeFrame': '0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Plasma Morphine Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine Sulfate 200 mg SR Capsules by Alpharma'}, {'id': 'OG001', 'title': 'KADIAN® 100mg Caps by Alpharma'}], 'classes': [{'categories': [{'measurements': [{'value': '9.50', 'spread': '3.89', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '18.00'}, {'value': '12.00', 'spread': '3.69', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '18.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve to the Last Measurable Time Point for Plasma Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine Sulfate 200 mg SR Capsules by Alpharma'}, {'id': 'OG001', 'title': 'KADIAN® 100mg Caps by Alpharma'}], 'classes': [{'categories': [{'measurements': [{'value': '795.0', 'spread': '231.2', 'groupId': 'OG000'}, {'value': '772.6', 'spread': '192.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'mean ratio', 'ciPctValue': '90', 'paramValue': '101.1', 'ciLowerLimit': '96.9', 'ciUpperLimit': '105.4', 'groupDescription': 'Statistical analysis of ln-transformed plasma morphine AUClast', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'ANOVA performed on the ratio of geometric means'}], 'paramType': 'MEAN', 'timeFrame': '0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36, 48 hrs post dose', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve to Infinity for Plasma Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine Sulfate 200 mg SR Capsules by Alpharma'}, {'id': 'OG001', 'title': 'KADIAN® 100mg Caps by Alpharma'}], 'classes': [{'categories': [{'measurements': [{'value': '875.7', 'spread': '282.0', 'groupId': 'OG000'}, {'value': '847.5', 'spread': '213.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'mean ratio', 'ciPctValue': '90', 'paramValue': '101.3', 'ciLowerLimit': '96.2', 'ciUpperLimit': '106.7', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.'}], 'paramType': 'MEAN', 'timeFrame': '0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Period 1: Treatment A or B', 'description': 'Treatment A (test product) followed by Treatment B (reference product)'}, {'id': 'FG001', 'title': 'Period 2: Treatment A or B', 'description': 'Treatment B (reference product) followed by Treatment A (test product)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': "didn't return for period 2", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': "Didn't receive drug in period 2", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Wash out period of at least 7 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Period 1: Treatment A or B', 'description': 'Treatment A (test product) followed by Treatment B (reference product)'}, {'id': 'BG001', 'title': 'Period 2: Treatment A or B', 'description': 'Treatment B (reference product) followed by Treatment A (test product)'}, {'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': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', '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': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '34', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '33', 'spread': '8.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], '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': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-13', 'studyFirstSubmitDate': '2008-09-24', 'resultsFirstSubmitDate': '2008-12-05', 'studyFirstSubmitQcDate': '2008-09-24', 'lastUpdatePostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-21', 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Morphine Concentration', 'timeFrame': '0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose'}], 'secondaryOutcomes': [{'measure': 'Time of Maximum Plasma Morphine Concentration', 'timeFrame': '0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose'}, {'measure': 'Area Under the Curve to the Last Measurable Time Point for Plasma Morphine', 'timeFrame': '0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36, 48 hrs post dose'}, {'measure': 'Area Under the Curve to Infinity for Plasma Morphine', 'timeFrame': '0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose'}]}, 'conditionsModule': {'keywords': ['bioequivalence', 'morphine sulfate sustained release capsules', 'KADIAN capsules', '200 mg'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x 100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered after a 10-hour overnight fast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be a male or non-pregnant, non-breast-feeding female.\n* Subject must be between 18 and 50 years of age inclusive.\n* Subject's body weight should be within +/- 15% of the ideal body weight for their height and estimated frame based on the Metropolitan Life Insurance Company Table and weigh a minimum of 50 kg (110 lbs).\n* Female subjects - not surgically sterile or at least two years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection), double barrier (condom and diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).\n* Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.\n* Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return to the study site for any outpatient visits.\n\nExclusion Criteria:\n\n* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.\n* Has a clinically significant abnormal finding on the physical exam, medical history or clinical laboratory results at screening.\n* History or presence of allergic or adverse response to the study drug or related drugs.\n* Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.\n* Has donated blood or plasma within 30 days prior to the first dose of study medication.\n* Has participated in another clinical trial within 30 days prior to first dose of study medication.\n* Has used any over-the-counter (OTC) medication including vitamins, within 7 days prior to the first dose of study medication without evaluation and approval by the study investigator.\n* Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 7 days prior to the first dose of study medication without evaluation and approval by the study investigator.\n* Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.\n* Has smoked or used tobacco products within 60 days prior to the first dose of study medication.\n* Has a history of substance abuse (including alcohol) in the past 5 years.\n* Is a female with a positive pregnancy test result.\n* Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).\n* Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV."}, 'identificationModule': {'nctId': 'NCT00759759', 'briefTitle': 'Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actavis Inc.'}, 'officialTitle': 'A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study Comparing the Bioavailability of a Morphine Sulfate Sustained Release Capsule 1 x 200mg to KADIAN 2 x 100mg Capsules Under Fasting Conditions', 'orgStudyIdInfo': {'id': '20-699-1N'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Treatment A (test product) followed by Treatment B (reference product)', 'interventionNames': ['Drug: morphine sulfate sustained-release capsules', 'Drug: KADIAN (morphine sulfate sustained-release) capsules']}, {'type': 'OTHER', 'label': '2', 'description': 'Treatment B (reference product) followed by Treatment A (test product)', 'interventionNames': ['Drug: morphine sulfate sustained-release capsules', 'Drug: KADIAN (morphine sulfate sustained-release) capsules']}], 'interventions': [{'name': 'morphine sulfate sustained-release capsules', 'type': 'DRUG', 'otherNames': ['Treatment A', 'Test product'], 'description': '1 x 200 mg, single-dose capsule', 'armGroupLabels': ['1', '2']}, {'name': 'KADIAN (morphine sulfate sustained-release) capsules', 'type': 'DRUG', 'otherNames': ['Treatment B', 'Reference product'], 'description': '2 x 100 mg, single-dose capsule', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'CEDRA Clinical Research, LLC', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Daniel V. Freeland, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEDRA Clinical Research, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actavis Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Daniel V. Freeland, DO', 'oldOrganization': 'CEDRA Clinical Research, LLC'}}}}