Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01100320
Status:
COMPLETED
Last Update Posted:
2010-05-11
First Post:
2010-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Stephen.Harris@Pharma.com', 'phone': '203-588-7592', 'title': 'Stephen Harris, MD', 'organization': 'Purdue Pharma L.P.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were followed until resolution or event/sequelae stabilized.', 'description': 'AEs were learned of through spontaneous reports, subject interview, or subject diaries.', 'eventGroups': [{'id': 'EG000', 'title': 'Reformulated OXY (Test)', 'description': 'Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.', 'otherNumAtRisk': 81, 'otherNumAffected': 35, 'seriousNumAtRisk': 81, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Original OxyContin® (OXY) (Reference)', 'description': 'Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.', 'otherNumAtRisk': 83, 'otherNumAffected': 22, 'seriousNumAtRisk': 83, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Systematic and nonsystematic assessments were used for reporting AEs.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'notes': 'Systematic and nonsystematic assessments were used for reporting AEs.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'notes': 'Systematic and nonsystematic assessments were used for reporting AEs.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'notes': 'Systematic and nonsystematic assessments were used for reporting AEs.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Substance Abuse (positive for cocaine, amphetamine, and MDMA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax - Maximum Observed Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reformulated OXY (Test)', 'description': 'Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.'}, {'id': 'OG001', 'title': 'Original OxyContin® (OXY) (Reference)', 'description': 'Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '61.5', 'spread': '12.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.9', 'ciLowerLimit': '95.40', 'ciUpperLimit': '104.52', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 72-hour period', 'description': 'Bioequivalence based on Cmax', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.'}, {'type': 'PRIMARY', 'title': 'AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reformulated OXY (Test)', 'description': 'Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.'}, {'id': 'OG001', 'title': 'Original OxyContin® (OXY) (Reference)', 'description': 'Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '537', 'spread': '135', 'groupId': 'OG000'}, {'value': '579', 'spread': '115', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.6', 'ciLowerLimit': '90.11', 'ciUpperLimit': '95.09', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 72-hour period', 'description': 'Bioequivalence based on AUC0-inf', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.'}, {'type': 'PRIMARY', 'title': 'AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reformulated OXY (Test)', 'description': 'Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.'}, {'id': 'OG001', 'title': 'Original OxyContin® (OXY) (Reference)', 'description': 'Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '535', 'spread': '134', 'groupId': 'OG000'}, {'value': '577', 'spread': '115', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.6', 'ciLowerLimit': '90.13', 'ciUpperLimit': '95.13', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 72-hour period', 'description': 'Bioequivalence based on AUC0-t', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reformulated OXY (Test) First', 'description': 'Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.'}, {'id': 'FG001', 'title': 'Original OxyContin® (OXY) (Reference) First', 'description': 'Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Positive Drug Screen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '22-Jan-2007 (date first ICF signed) to 30-Mar-2007 (last subject follow-up) at 1 site in the US (Austin, TX)', 'preAssignmentDetails': '174 subjects screened; 84 screen failures; 2 discontinued prior to dosing; 88 randomized and dosed; 14 terminated early; 74 completed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized Safety Population', 'description': 'Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-06', 'studyFirstSubmitDate': '2010-04-07', 'resultsFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-07', 'lastUpdatePostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-13', 'studyFirstPostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Plasma Concentration', 'timeFrame': 'Blood samples collected over 72-hour period', 'description': 'Bioequivalence based on Cmax'}, {'measure': 'AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'timeFrame': 'Blood samples collected over 72-hour period', 'description': 'Bioequivalence based on AUC0-inf'}, {'measure': 'AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration', 'timeFrame': 'Blood samples collected over 72-hour period', 'description': 'Bioequivalence based on AUC0-t'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy subjects', 'Opioid'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fed state.', 'detailedDescription': 'Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females aged 18 to 50, inclusive.\n* Body weight ranging from 50 to 100 kg and a BMI ≥18 and ≤34 (kg/m2).\n* Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and ECG.\n* Females of child-bearing potential must be using an adequate and reliable method of contraception.\n\nExclusion Criteria:\n\n* Females who are pregnant or lactating.\n* Any history of or current drug or alcohol abuse for 5 years.\n* History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.\n* Use of an opioid-containing medication in the past 30 days.\n* History of known sensitivity to oxycodone, naltrexone, or related compounds.\n* Any history of frequent nausea or emesis regardless of etiology.\n* Any history of seizures or head trauma with current sequelae.\n* Participation in a clinical drug study during the 30 days preceding the initial dose in this study.\n* Any significant illness during the 30 days preceding the initial dose in this study.\n* Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.\n* Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.\n* Consumption of alcoholic beverages within forty-eight (48) hours of initial study drug administration (Day 1) or anytime following initial study drug administration.\n* History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.\n* Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.\n* Positive results for urine drug screen or alcohol screen at Check-in of each period, and HBsAg, HBsAb (unless immunized), anti-HCV.\n* Positive Naloxone HCl challenge test.\n* Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities."}, 'identificationModule': {'nctId': 'NCT01100320', 'briefTitle': 'A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Purdue Pharma LP'}, 'officialTitle': 'A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fed Bioequivalence of Oxycodone Tamper Resistant (OTR) 40-mg Tablets to OxyContin® 40-mg Tablets', 'orgStudyIdInfo': {'id': 'OTR1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reformulated OXY 40 mg', 'description': 'Reformulated OXY 40 mg x 1 dose', 'interventionNames': ['Drug: Reformulated OXY (oxycodone HCl)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Original OxyContin® (OXY) 40 mg', 'description': 'Original OxyContin® (OXY) 40 mg x 1 dose', 'interventionNames': ['Drug: Original OxyContin® (OXY) (oxycodone HCl)']}], 'interventions': [{'name': 'Reformulated OXY (oxycodone HCl)', 'type': 'DRUG', 'description': 'Reformulated OXY 40-mg tablet x 1 dose taken with food', 'armGroupLabels': ['Reformulated OXY 40 mg']}, {'name': 'Original OxyContin® (OXY) (oxycodone HCl)', 'type': 'DRUG', 'description': 'Original OxyContin® (OXY) 40-mg tablet x 1 dose taken with food', 'armGroupLabels': ['Original OxyContin® (OXY) 40 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78752', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Clinical Research Unit - Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue Pharma LP', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'Purdue Pharma L.P.'}}}}