Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-01 @ 5:40 PM
Study NCT ID:
NCT02504320
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2015-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 1, Febuxostat XR Relative Bioavailability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C006011', 'term': 'F 4'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director, Clinical Science', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first administration of study drug on Day 1 of Period 1 up to 30 days after the last dose of study drug or Early termination visit (approximately up to 95 days)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Set included all participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Regimen A: Febuxostat XR 80 mg Formulation 1', 'description': 'Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.', 'otherNumAtRisk': 76, 'otherNumAffected': 6, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Regimen B: Febuxostat XR 80 mg Formulation 2', 'description': 'Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.', 'otherNumAtRisk': 76, 'otherNumAffected': 9, 'seriousNumAtRisk': 76, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Regimen C: Febuxostat XR 80 mg Formulation 3', 'description': 'Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.', 'otherNumAtRisk': 77, 'otherNumAffected': 7, 'seriousNumAtRisk': 77, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Regimen D: Febuxostat XR 80 mg Formulation 4', 'description': 'Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.', 'otherNumAtRisk': 76, 'otherNumAffected': 7, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Trichomoniasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}], 'seriousEvents': [{'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 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period, and participants nested within sequence as fixed effects.', 'groupDescription': 'Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7709', 'ciLowerLimit': '0.6767', 'ciUpperLimit': '0.8782', 'estimateComment': 'Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.', 'groupDescription': 'Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9389', 'ciLowerLimit': '0.8246', 'ciUpperLimit': '1.0689', 'estimateComment': 'Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.', 'groupDescription': 'Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and 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Here, number of participants analyzed is the participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen A: Febuxostat XR 80 mg Formulation 1', 'description': 'Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.'}, {'id': 'OG001', 'title': 'Regimen B: Febuxostat XR 80 mg Formulation 2', 'description': 'Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.'}, {'id': 'OG002', 'title': 'Regimen C: Febuxostat XR 80 mg Formulation 3', 'description': 'Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.'}, {'id': 'OG003', 'title': 'Regimen D: Febuxostat XR 80 mg Formulation 4', 'description': 'Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '9395.6014', 'spread': '3961.55203', 'groupId': 'OG000'}, {'value': '7971.0624', 'spread': '3291.36390', 'groupId': 'OG001'}, {'value': '8652.7080', 'spread': '3673.91666', 'groupId': 'OG002'}, {'value': '8817.3600', 'spread': '3429.94880', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0435', 'ciLowerLimit': '0.9840', 'ciUpperLimit': '1.1066', 'estimateComment': 'Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.', 'groupDescription': 'Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8777', 'ciLowerLimit': '0.8274', 'ciUpperLimit': '0.9311', 'estimateComment': 'Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.', 'groupDescription': 'Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9540', 'ciLowerLimit': '0.8996', 'ciUpperLimit': '1.0117', 'estimateComment': 'Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.', 'groupDescription': 'Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose', 'description': 'AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen A: Febuxostat XR 80 mg Formulation 1', 'description': 'Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.'}, {'id': 'OG001', 'title': 'Regimen B: Febuxostat XR 80 mg Formulation 2', 'description': 'Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.'}, {'id': 'OG002', 'title': 'Regimen C: Febuxostat XR 80 mg Formulation 3', 'description': 'Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.'}, {'id': 'OG003', 'title': 'Regimen D: Febuxostat XR 80 mg Formulation 4', 'description': 'Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '9368.0744', 'spread': '3944.01280', 'groupId': 'OG000'}, {'value': '8278.6143', 'spread': '3205.31556', 'groupId': 'OG001'}, {'value': '8938.8765', 'spread': '3746.60153', 'groupId': 'OG002'}, {'value': '9102.3700', 'spread': '3430.45699', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0283', 'ciLowerLimit': '0.9691', 'ciUpperLimit': '1.0911', 'estimateComment': 'Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.', 'groupDescription': 'Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9056', 'ciLowerLimit': '0.8516', 'ciUpperLimit': '0.9630', 'estimateComment': 'Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.', 'groupDescription': 'Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Point Estimates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9463', 'ciLowerLimit': '0.8909', 'ciUpperLimit': '1.0051', 'estimateComment': 'Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.', 'groupDescription': 'Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose', 'description': 'AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence ABDC', 'description': 'Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).'}, {'id': 'FG001', 'title': 'Treatment Sequence DACB', 'description': 'Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).'}, {'id': 'FG002', 'title': 'Treatment Sequence CDBA', 'description': 'Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).'}, {'id': 'FG003', 'title': 'Treatment Sequence BCAD', 'description': 'Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Positive Drug Screen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Positive Drug Screen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Positive Drug Screen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 1 investigative site in the United States from 29 June 2015 to 01 October 2015.', 'preAssignmentDetails': 'Healthy participants were enrolled equally in 1 of 4 sequences which determined order of treatment: Regimen A (Febuxostat extended release \\[XR\\] 80 mg capsule \\[cap\\] Formulation \\[F\\] 1), B (Febuxostat XR 80 mg cap F2), C (Febuxostat XR 80 mg cap F3) and D (Febuxostat XR 80 mg cap F4). Each regimen is separated by a 7-day washout period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Sequence ABDC', 'description': 'Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).'}, {'id': 'BG001', 'title': 'Treatment Sequence DACB', 'description': 'Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).'}, {'id': 'BG002', 'title': 'Treatment Sequence CDBA', 'description': 'Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).'}, {'id': 'BG003', 'title': 'Treatment Sequence BCAD', 'description': 'Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '7.56', 'groupId': 'BG000'}, {'value': '30.7', 'spread': '6.51', 'groupId': 'BG001'}, {'value': '34.0', 'spread': '8.87', 'groupId': 'BG002'}, {'value': '31.2', 'spread': '7.78', 'groupId': 'BG003'}, {'value': '31.9', 'spread': '7.70', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '167.6', 'spread': '10.13', 'groupId': 'BG000'}, {'value': '171.1', 'spread': '11.75', 'groupId': 'BG001'}, {'value': '167.5', 'spread': '9.70', 'groupId': 'BG002'}, {'value': '165.7', 'spread': '6.67', 'groupId': 'BG003'}, {'value': '167.9', 'spread': '9.71', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '72.98', 'spread': '12.685', 'groupId': 'BG000'}, {'value': '79.05', 'spread': '11.846', 'groupId': 'BG001'}, {'value': '71.22', 'spread': '12.350', 'groupId': 'BG002'}, {'value': '69.72', 'spread': '11.015', 'groupId': 'BG003'}, {'value': '73.17', 'spread': '12.273', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.84', 'spread': '2.663', 'groupId': 'BG000'}, {'value': '26.98', 'spread': '2.722', 'groupId': 'BG001'}, {'value': '25.29', 'spread': '3.168', 'groupId': 'BG002'}, {'value': '25.28', 'spread': '2.802', 'groupId': 'BG003'}, {'value': '25.83', 'spread': '2.878', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Classification', 'classes': [{'title': 'Has Never Smoked', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}, {'title': 'Is a Current Smoker', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Is an Ex-smoker', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Classification', 'classes': [{'title': 'Has Never Drunk', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}, {'title': 'Is a Current Drinker', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}, {'title': 'Is an Ex-drinker', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Xanthine/Caffeine Consumption', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Female Reproductive Status', 'classes': [{'title': 'Not Applicable (Participant is Male)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}, {'title': 'Female of Childbearing Potential', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}, {'title': 'Surgically Sterile', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Postmenopausal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Estimated Glomerular Filtration Rate (eGFR)', 'classes': [{'title': 'Screening (n=19, 19, 19, 20)', 'categories': [{'measurements': [{'value': '111.42', 'spread': '11.815', 'groupId': 'BG000'}, {'value': '112.84', 'spread': '11.987', 'groupId': 'BG001'}, {'value': '108.05', 'spread': '11.664', 'groupId': 'BG002'}, {'value': '114.00', 'spread': '13.377', 'groupId': 'BG003'}, {'value': '111.61', 'spread': '12.211', 'groupId': 'BG004'}]}]}, {'title': 'Check-in (n=19, 19, 20, 20)', 'categories': [{'measurements': [{'value': '115.53', 'spread': '12.294', 'groupId': 'BG000'}, {'value': '115.26', 'spread': '12.229', 'groupId': 'BG001'}, {'value': '112.00', 'spread': '10.964', 'groupId': 'BG002'}, {'value': '116.55', 'spread': '12.845', 'groupId': 'BG003'}, {'value': '114.82', 'spread': '11.987', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'eGFR is calculated using the Cockcroft-Gault formula.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Set included all participants who were enrolled and received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-25', 'studyFirstSubmitDate': '2015-07-20', 'resultsFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2015-07-20', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-25', 'studyFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose', 'description': 'Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.'}, {'measure': 'Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose', 'description': 'AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.'}, {'measure': 'Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose', 'description': 'AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study will assess the relative bioavailability, safety and tolerability following administration of 80 mg single oral doses of 4 febuxostat extended release (XR) formulations.', 'detailedDescription': 'The drug being tested is this study is febuxostat XR. Four different formulations of febuxostat XR are being tested to see how the drug moves through the body. This study will look at safety and side effects in people who take febuxostat XR.\n\nThis cross-over study will enroll approximately 78 patients. Participants will be randomly assigned to 1of 4 sequences which will determine the order of the 4 treatments received:\n\n* Febuxostat XR 80 mg capsule Formulation 1\n* Febuxostat XR 80 mg capsule Formulation 2\n* Febuxostat XR 80 mg capsule Formulation 3\n* Febuxostat XR 80 mg capsule Formulation 4\n\nParticipants will take 1 dose on Day 1 with a washout period between each period.\n\nThis single-center trial will be conducted in the United States. The overall time to participate in this study is up to 80 days. Participants will make multiple visits to the clinic including a period of confinement, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.\n2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.\n3. Is a healthy male or female and aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.\n4. Weighs at least 50.0 kg and has a body mass index (BMI) from 18.0 to 30.0 kg/m2, inclusive at Screening.\n5. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose.\n6. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent,\n7. Is willing to refrain from strenuous exercise from Day -1 of Period 1 until Study Exit (Day 3 of Period 4).\n8. Has estimated glomerular filtration rate (eGFR) ≥90 mL/min at Screening and Check-in (Day -1 of Period 1).\n\nExclusion Criteria:\n\n1. Has received any investigational compound within 30 days prior to the first dose of study medication.\n2. Has received febuxostat in a previous clinical study or as a therapeutic agent.\n3. Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study.\n4. Has uncontrolled, clinically significant (CS) disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.\n5. Has a known hypersensitivity to any component of the formulation of XO inhibitors, xanthine compounds, caffeine, or any component of the formulation of febuxostat capsules."}, 'identificationModule': {'nctId': 'NCT02504320', 'briefTitle': 'Phase 1, Febuxostat XR Relative Bioavailability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 1, Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Assess the Relative Bioavailability of Four 80 mg Febuxostat XR Formulations', 'orgStudyIdInfo': {'id': 'Febuxostat XR-1011'}, 'secondaryIdInfos': [{'id': 'U1111-1168-1117', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence ABDC', 'description': 'Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).', 'interventionNames': ['Drug: Febuxostat XR 80 mg Capsule F1', 'Drug: Febuxostat XR 80 mg Capsule F2', 'Drug: Febuxostat XR 80 mg Capsule F3', 'Drug: Febuxostat XR 80 mg Capsule F4']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence DACB', 'description': 'Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).', 'interventionNames': ['Drug: Febuxostat XR 80 mg Capsule F1', 'Drug: Febuxostat XR 80 mg Capsule F2', 'Drug: Febuxostat XR 80 mg Capsule F3', 'Drug: Febuxostat XR 80 mg Capsule F4']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence CDBA', 'description': 'Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).', 'interventionNames': ['Drug: Febuxostat XR 80 mg Capsule F1', 'Drug: Febuxostat XR 80 mg Capsule F2', 'Drug: Febuxostat XR 80 mg Capsule F3', 'Drug: Febuxostat XR 80 mg Capsule F4']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence BCAD', 'description': 'Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).', 'interventionNames': ['Drug: Febuxostat XR 80 mg Capsule F1', 'Drug: Febuxostat XR 80 mg Capsule F2', 'Drug: Febuxostat XR 80 mg Capsule F3', 'Drug: Febuxostat XR 80 mg Capsule F4']}], 'interventions': [{'name': 'Febuxostat XR 80 mg Capsule F1', 'type': 'DRUG', 'description': 'Febuxostat extended-release (XR) capsules formulation 1', 'armGroupLabels': ['Treatment Sequence ABDC', 'Treatment Sequence BCAD', 'Treatment Sequence CDBA', 'Treatment Sequence DACB']}, {'name': 'Febuxostat XR 80 mg Capsule F2', 'type': 'DRUG', 'description': 'Febuxostat XR capsules formulation 2', 'armGroupLabels': ['Treatment Sequence ABDC', 'Treatment Sequence BCAD', 'Treatment Sequence CDBA', 'Treatment Sequence DACB']}, {'name': 'Febuxostat XR 80 mg Capsule F3', 'type': 'DRUG', 'description': 'Febuxostat XR capsules formulation 3', 'armGroupLabels': ['Treatment Sequence ABDC', 'Treatment Sequence BCAD', 'Treatment Sequence CDBA', 'Treatment Sequence DACB']}, {'name': 'Febuxostat XR 80 mg Capsule F4', 'type': 'DRUG', 'description': 'Febuxostat XR capsules formulation 4', 'armGroupLabels': ['Treatment Sequence ABDC', 'Treatment Sequence BCAD', 'Treatment Sequence CDBA', 'Treatment Sequence DACB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Medical Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}