Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT01154218
Status:
COMPLETED
Last Update Posted:
2011-10-24
First Post:
2010-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077547', 'term': 'Crizotinib'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.', 'otherNumAtRisk': 36, 'otherNumAffected': 21, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.', 'otherNumAtRisk': 36, 'otherNumAffected': 24, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.', 'otherNumAtRisk': 36, 'otherNumAffected': 20, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.', 'otherNumAtRisk': 36, 'otherNumAffected': 21, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastrointestinal sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2890.0', 'spread': '1021.8', 'groupId': 'OG000'}, {'value': '2665.0', 'spread': '1190.4', 'groupId': 'OG001'}, {'value': '2887.0', 'spread': '1109.6', 'groupId': 'OG002'}, {'value': '2475.0', 'spread': '1037.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.56', 'ciLowerLimit': '91.49', 'ciUpperLimit': '108.33', 'groupDescription': 'Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.93', 'ciLowerLimit': '98.26', 'ciUpperLimit': '116.35', 'groupDescription': 'Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '85.76', 'ciLowerLimit': '78.88', 'ciUpperLimit': '93.25', 'groupDescription': 'Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose', 'description': 'AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2763.0', 'spread': '989.0', 'groupId': 'OG000'}, {'value': '2531.0', 'spread': '1158.0', 'groupId': 'OG001'}, {'value': '2761.0', 'spread': '1078.4', 'groupId': 'OG002'}, {'value': '2359.0', 'spread': '1013.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.60', 'ciLowerLimit': '91.30', 'ciUpperLimit': '108.66', 'groupDescription': 'Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '107.56', 'ciLowerLimit': '98.58', 'ciUpperLimit': '117.35', 'groupDescription': 'Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '85.52', 'ciLowerLimit': '78.45', 'ciUpperLimit': '93.22', 'groupDescription': 'Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '8.00'}, {'value': '5.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '5.00', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '5.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '8.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.62', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '35.28', 'spread': '6.39', 'groupId': 'OG001'}, {'value': '34.85', 'spread': '4.94', 'groupId': 'OG002'}, {'value': '35.41', 'spread': '5.49', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '126.00', 'spread': '36.58', 'groupId': 'OG000'}, {'value': '119.30', 'spread': '50.88', 'groupId': 'OG001'}, {'value': '135.00', 'spread': '47.84', 'groupId': 'OG002'}, {'value': '116.10', 'spread': '45.58', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.97', 'ciLowerLimit': '96.55', 'ciUpperLimit': '118.51', 'groupDescription': 'Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '111.32', 'ciLowerLimit': '100.47', 'ciUpperLimit': '123.33', 'groupDescription': 'Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.22', 'ciLowerLimit': '77.89', 'ciUpperLimit': '95.43', 'groupDescription': 'Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.49', 'spread': '30.42', 'groupId': 'OG000'}, {'value': '93.78', 'spread': '49.80', 'groupId': 'OG001'}, {'value': '86.57', 'spread': '53.63', 'groupId': 'OG002'}, {'value': '101.00', 'spread': '38.60', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4290.0', 'spread': '1672.4', 'groupId': 'OG000'}, {'value': '4703.0', 'spread': '2874.7', 'groupId': 'OG001'}, {'value': '4313.0', 'spread': '3880.9', 'groupId': 'OG002'}, {'value': '5096.0', 'spread': '2302.0', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '432.20', 'spread': '219.76', 'groupId': 'OG000'}, {'value': '391.20', 'spread': '255.12', 'groupId': 'OG001'}, {'value': '436.90', 'spread': '246.34', 'groupId': 'OG002'}, {'value': '325.00', 'spread': '192.81', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.03', 'ciLowerLimit': '90.16', 'ciUpperLimit': '110.97', 'groupDescription': 'Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.85', 'ciLowerLimit': '98.11', 'ciUpperLimit': '120.77', 'groupDescription': 'Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '74.87', 'ciLowerLimit': '67.55', 'ciUpperLimit': '82.98', 'groupDescription': 'Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '442.00', 'spread': '221.96', 'groupId': 'OG000'}, {'value': '402.10', 'spread': '257.39', 'groupId': 'OG001'}, {'value': '447.10', 'spread': '248.23', 'groupId': 'OG002'}, {'value': '341.80', 'spread': '194.91', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.08', 'ciLowerLimit': '90.46', 'ciUpperLimit': '110.73', 'groupDescription': 'Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.47', 'ciLowerLimit': '98.03', 'ciUpperLimit': '120.02', 'groupDescription': 'Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '76.59', 'ciLowerLimit': '69.23', 'ciUpperLimit': '84.74', 'groupDescription': 'Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N = 35' is signifying those participants who were evaluable for this measure at the specified time point for crizotinib CIC fed arm group."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.20', 'spread': '12.48', 'groupId': 'OG000'}, {'value': '29.74', 'spread': '15.19', 'groupId': 'OG001'}, {'value': '33.04', 'spread': '12.12', 'groupId': 'OG002'}, {'value': '23.64', 'spread': '10.85', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.11', 'ciLowerLimit': '92.84', 'ciUpperLimit': '112.31', 'groupDescription': 'Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.87', 'ciLowerLimit': '98.98', 'ciUpperLimit': '119.75', 'groupDescription': 'Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of Adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '71.94', 'ciLowerLimit': '65.46', 'ciUpperLimit': '79.05', 'groupDescription': 'Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crizotinib IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg IRT (Treatment A \\[Reference 1\\]) in fasted state in any intervention period.'}, {'id': 'OG001', 'title': 'Crizotinib PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC (Treatment B \\[Reference 2\\]) in fasted state in any intervention period.'}, {'id': 'OG002', 'title': 'Crizotinib CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment C \\[Test for bioequivalence (BE), Reference for Food effect\\]) in fasted state in any intervention period.'}, {'id': 'OG003', 'title': 'Crizotinib CIC Fed', 'description': 'Single oral dose of crizotinib 250 mg CIC (Treatment D \\[Test High Fat\\]) in fed state in any intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '8.02'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '8.00'}, {'value': '5.00', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '10.00'}, {'value': '6.00', 'groupId': 'OG003', 'lowerLimit': '2.00', 'upperLimit': '10.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Crizotinib 250 mg IRT Fasted, PIC Fasted, CIC Fasted, CIC Fed', 'description': 'Single oral dose of crizotinib 250 milligram (mg) immediate release tablet (IRT) in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg powder in capsule (PIC) in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg commercial image capsule (CIC) in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fed state in fourth intervention period. A washout period of at least 14 days was maintained between each period.'}, {'id': 'FG001', 'title': 'Crizotinib 250 mg PIC Fasted, CIC Fed, IRT Fasted, CIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg PIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in second intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.'}, {'id': 'FG002', 'title': 'Crizotinib 250 mg CIC Fasted, IRT Fasted, CIC Fed, PIC Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in third intervention period; and single oral dose of crizotinib 250 mg PIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.'}, {'id': 'FG003', 'title': 'Crizotinib 250 mg CIC Fed, CIC Fasted, PIC Fasted, IRT Fasted', 'description': 'Single oral dose of crizotinib 250 mg CIC in fed state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg PIC in fasted state in third intervention period; and single oral dose of crizotinib 250 mg IRT in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.'}], 'periods': [{'title': 'First Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (at Least 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (at Least 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (at Least 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Fourth Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes participants randomized to receive any treatment (crizotinib 250 mg IRT fasted first, crizotinib 250 mg PIC fasted first, crizotinib 250 mg CIC fasted first and crizotinib 250 mg CIC fed).'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '8.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', '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': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-20', 'studyFirstSubmitDate': '2010-06-29', 'resultsFirstSubmitDate': '2011-09-12', 'studyFirstSubmitQcDate': '2010-06-29', 'lastUpdatePostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-12', 'studyFirstPostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose', 'description': 'AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose'}, {'measure': 'Plasma Decay Half Life (t1/2)', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Apparent Oral Clearance (CL/F)', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.'}, {'measure': 'Apparent Volume of Distribution (Vz/F)', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose', 'description': 'AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)', 'timeFrame': '0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioequivalence', 'food effect', 'pharmacokinetics', 'crizotinib'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081011&StudyName=Bioequivalence%20And%20Food%20Effect%20Study%20Comparing%20The%20Commercial%20Formulation%20Of%20Crizotinib%20To%20Its%20Clinical%20Study%20Formulations%20And%20Commercial%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC relative to Powder in Capsule (PIC) of crizotinib, and lack of an effect of high fat meal on the pharmacokinetics (PK) of crizotinib when administered as CIC Formulation in healthy volunteers.', 'detailedDescription': 'The purpose of this study is to demonstrate bioequivalence of the CIC relative to IRT and CIC relative to PIC, and lack of an effect of food on the PK of crizotinib in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female of non-childbearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\\^2; and a total body weight \\>50 kg (110 lbs)\n\nExclusion Criteria:\n\n* Subjects who are smoking, or with evidence of disease, conditions affecting absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, use of prescription, nonprescription drugs and dietary supplement within 7 days, or blood donation of 500 mL within 56 days.'}, 'identificationModule': {'nctId': 'NCT01154218', 'briefTitle': 'Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Single Dose Bioequivalence And Food Effect Study In Healthy Volunteers Comparing The Commercial Image Capsules To The Immediate Release Tablets And Powder In Capsule Formulations Of Crizotinib (PF-02341066), And The Commercial Image Capsule In The Fasted To Fed State', 'orgStudyIdInfo': {'id': 'A8081011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'All subjects will receive four treatments in one of the indicated orders:\n\nA-B-C-D, B-D-A-C, C-A-D-B, D-C-B-A', 'interventionNames': ['Drug: crizotinib']}], 'interventions': [{'name': 'crizotinib', 'type': 'DRUG', 'description': 'Treatment A (Reference 1): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg IRT and 2 × 100-mg IRTs.\n\nTreatment B (Reference 2): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg PIC and 2 × 100 mg PICs.\n\nTreatment C (Test for BE, Reference for Food Effect): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 250-mg CIC.\n\nTreatment D (Test High Fat): a 250 mg single dose of crizotinib administered with a high-fat meal as 1 × 250-mg CIC', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}