Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 9:11 AM
Study NCT ID:
NCT01055769
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2010-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Day 3', '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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Linezolid 600 mg Oral Suspension', 'description': 'Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Linezolid 600 mg Tablet', 'description': 'Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v13.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid 600 mg Oral Suspension', 'description': 'Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}, {'id': 'OG001', 'title': 'Linezolid 600 mg Tablet', 'description': 'Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}], 'classes': [{'categories': [{'measurements': [{'value': '108.90', 'spread': '21.66', 'groupId': 'OG000'}, {'value': '112.00', 'spread': '24.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric Means Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.81', 'ciLowerLimit': '93.11', 'ciUpperLimit': '102.75', 'groupDescription': 'Natural log transformed AUClast of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '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. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.'}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose', 'description': 'Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).', 'unitOfMeasure': 'microgram*hour/milliliter (mcg*h/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid 600 mg Oral Suspension', 'description': 'Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}, {'id': 'OG001', 'title': 'Linezolid 600 mg Tablet', 'description': 'Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.51', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '13.68', 'spread': '3.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric Means Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '113.67', 'ciLowerLimit': '105.26', 'ciUpperLimit': '122.75', 'groupDescription': 'Natural log transformed Cmax of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '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. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.'}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose', 'description': 'Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.', 'unitOfMeasure': 'microgram/milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid 600 mg Oral Suspension', 'description': 'Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}, {'id': 'OG001', 'title': 'Linezolid 600 mg Tablet', 'description': 'Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}], 'classes': [{'categories': [{'measurements': [{'value': '109.20', 'spread': '21.72', 'groupId': 'OG000'}, {'value': '112.60', 'spread': '24.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.65', 'ciLowerLimit': '92.92', 'ciUpperLimit': '102.63', 'groupDescription': 'Natural log transformed AUCinf of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '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. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.'}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-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': 'mcg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid 600 mg Oral Suspension', 'description': 'Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}, {'id': 'OG001', 'title': 'Linezolid 600mg Tablet', 'description': 'Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose', 'description': 'The time of the first occurrence of peak concentration observed directly from data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid 600 mg Oral Suspension', 'description': 'Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}, {'id': 'OG001', 'title': 'Linezolid 600 mg Tablet', 'description': 'Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.08', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose', 'description': 'Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Linezolid 600 mg Oral Suspension, Then Linezolid 600 mg Tablet', 'description': 'Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).'}, {'id': 'FG001', 'title': 'Linezolid 600 mg Tablet, Then Linezolid 600 mg Oral Suspension', 'description': 'Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of Atleast 4 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at a single site in China.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Linezolid', 'description': 'Linezolid 600 mg once (oral suspension or tablet) in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'spread': '2.1', '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': '20', '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': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-30', 'studyFirstSubmitDate': '2010-01-22', 'resultsFirstSubmitDate': '2011-03-04', 'studyFirstSubmitQcDate': '2010-01-22', 'lastUpdatePostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-04', 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose', 'description': 'Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose', 'description': 'Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]', 'timeFrame': '0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-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': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose', 'description': 'The time of the first occurrence of peak concentration observed directly from data.'}, {'measure': 'Terminal Half-Life (t1/2)', 'timeFrame': '0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose', 'description': 'Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bio-equivalence', 'Linezolid OS', 'Linezolid tablet'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5951152&StudyName=Bioequivalence%20Study%20Comparing%20Linezolid%20600%20Mg%20Oral%20Suspension%20With%20600%20Mg%20Tablet%20In%20Chinese%20Healthy%20Male%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.', 'detailedDescription': 'To support Linezolid NDA in China.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers.\n* 18-40 years old, male.\n* BMI 19-24kg/m2.\n\nExclusion Criteria:\n\n* Alcohol, drug, smoke user.\n* Sensitive to oxazolidinones antibiotics class drug or heparin.\n* Severe medical or psychiatric condition or laboratory abnormality.\n* Blood donation.\n* 12-ECG abnormal.\n* Treatment with study drug; clinically significant.'}, 'identificationModule': {'nctId': 'NCT01055769', 'briefTitle': 'Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open Label, Single Dose, 2-Way, Randomized Cross-Over Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'A5951152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'description': 'Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG.', 'interventionNames': ['Drug: Linezolid']}, {'type': 'OTHER', 'label': 'Group 2', 'description': 'Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG.', 'interventionNames': ['Drug: Linezolid']}], 'interventions': [{'name': 'Linezolid', 'type': 'DRUG', 'otherNames': ['Zyvox'], 'description': '1. Linezolid OS 600 MG\n2. Linezolid Tablet 600 MG', 'armGroupLabels': ['Group 1']}, {'name': 'Linezolid', 'type': 'DRUG', 'otherNames': ['Zyvox'], 'description': '1. Linezolid Tablet 600 MG\n2. Linezolid OS 600 MG', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}