Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT01044706
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2010-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet in Healthy Subjects Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C053541', 'term': 'bicalutamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bang.xu@ucb.com', 'phone': '812-523-5453', 'title': 'Bang Qian Xu, Ph.D., Director of Biopharmaceutics', 'organization': 'Kremers Urban Development Company'}, 'certainAgreement': {'otherDetails': 'This document contains trade secrets and commercial information that is confidential and may not be disclosed to third parties. Persons to whom this study protocol is disclosed must be informed that all the information herein is confidential and may not be further divulged. These restrictions will apply as well to all future communications if deemed privileged or confidential. Publication of the study results may only be allowed with written permission from the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bicalutamide 50 mg Tablet', 'description': 'Bicalutamide 50 mg Tablet', 'otherNumAtRisk': 30, 'otherNumAffected': 11, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Casodex® 50 mg Tablet', 'description': 'Casodex® 50 mg Tablet', 'otherNumAtRisk': 30, 'otherNumAffected': 18, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pain abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Edema inject site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hysn inject site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Cramp leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pain back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Urine frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC0-144 (Area Under the Concentration-time Curve From Time Zero to 144 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bicalutamide 50 mg Tablet', 'description': 'Bicalutamide 50 mg Tablet'}, {'id': 'OG001', 'title': 'Casodex® 50 mg Tablet', 'description': 'Casodex® 50 mg Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '114386.56', 'spread': '14285.37', 'groupId': 'OG000'}, {'value': '105377.55', 'spread': '11989.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of T/R geometric mean x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.46', 'ciLowerLimit': '102.79', 'ciUpperLimit': '114.44', 'pValueComment': 'Differences were declared statistically significant at the 5% level (p\\<0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0321', 'estimateComment': 'Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.', 'groupDescription': 'Using GLM procedures in SAS, ANOVA was performed on ln-transformed AUC0-144 at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for AUC0-144 hour.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'degrees of freedom 55', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\\<0.05).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '144 hour', 'description': 'AUC0-144 (area under the concentration-time curve from time zero to 144 hour post-dose)', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'PRIMARY', 'title': 'Cmax (Maximum Observed Concentration of Drug Substance in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bicalutamide 50 mg Tablet', 'description': 'Bicalutamide 50 mg Tablet'}, {'id': 'OG001', 'title': 'Casodex® 50 mg Tablet', 'description': 'Casodex® 50 mg Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1253.60', 'spread': '138.02', 'groupId': 'OG000'}, {'value': '1134.86', 'spread': '122.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of T/R geometric mean x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '110.50', 'ciLowerLimit': '105.43', 'ciUpperLimit': '115.82', 'pValueComment': 'Differences were declared statistically significant at the 5% level (p\\<0.05).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0281', 'estimateComment': 'Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.', 'groupDescription': 'Using GLM procedures in SAS, ANOVA was performed on ln-transformed Cmax at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for Cmax.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'degrees of freedom 56', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\\<0.05).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '144 hour', 'description': 'maximum observed concentration of drug substance in plasma', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bicalutamide 50 mg Tablet', 'description': 'Bicalutamide 50 mg Tablet'}, {'id': 'FG001', 'title': 'Casodex® 50 mg Tablet', 'description': 'Casodex® 50 mg Tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'healthy subjects recruited in April 2005 by sfbc Anapharm at 2050, Boul. Rene-Levesque Quest, Saint-Foy, Quebec, Canada G1V 2K8', 'preAssignmentDetails': 'This was a single center, bioequivalence, open-label, single-dose, 1-way parallel study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bicalutamide 50 mg Tablet', 'description': 'Bicalutamide 50 mg Tablet'}, {'id': 'BG001', 'title': 'Casodex® 50 mg Tablet', 'description': 'Casodex® 50 mg Tablet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.13', 'spread': '14.10', 'groupId': 'BG000'}, {'value': '37.93', 'spread': '14.41', 'groupId': 'BG001'}, {'value': '39.03', 'spread': '14.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-28', 'studyFirstSubmitDate': '2010-01-07', 'resultsFirstSubmitDate': '2010-02-08', 'studyFirstSubmitQcDate': '2010-01-07', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-08', 'studyFirstPostDateStruct': {'date': '2010-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-144 (Area Under the Concentration-time Curve From Time Zero to 144 Hour Post-dose)', 'timeFrame': '144 hour', 'description': 'AUC0-144 (area under the concentration-time curve from time zero to 144 hour post-dose)'}, {'measure': 'Cmax (Maximum Observed Concentration of Drug Substance in Plasma)', 'timeFrame': '144 hour', 'description': 'maximum observed concentration of drug substance in plasma'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bioequivalency'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablet (test) versus Casodex® (reference), administered as 1 x 50 mg tablet under fed conditions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male, non-smoker, 18 years of age and older;\n* Capable of consent;\n* BMI≥19.0 and \\<30.0 kg/m2.\n\nExclusion Criteria:\n\n* Clinically significant illnesses within 4 weeks prior to the administration of the study medication.\n* Clinically significant surgery within 4 weeks prior to the administration of the study medication.\n* Any clinically significant abnormality found during medical screening.\n* Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.\n* Abnormal laboratory tests judged clinically significant.\n* Positive testing for hepatitis B, hepatitis C, or HIV at screening.\n* ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.\n* History of significant alcohol abuse or drug abuse within one year prior to the screening visit.\n* Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \\[1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\\]).\n* Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \\[PCP\\] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.\n* History of allergic reactions to heparin, bicalutamide, or other related drugs.\n* Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.\n* Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.\n* Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.\n* Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.\n* Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins. garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.\n* Difficulty to swallow study medication.\n* Use of any tobacco products in the 6 months preceding drug administration.\n* Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.\n* A depot injection or an implant of any drug within 3 months prior to administration of study medication.\n* Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:\n\n * 50 mL to 300 mL of whole blood within 30 days,\n * 301 mL to 500 mL of whole blood within 45 days, or\n * more than 500 mL of whole blood within 56 days prior to drug administration."}, 'identificationModule': {'nctId': 'NCT01044706', 'briefTitle': 'Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet in Healthy Subjects Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kremers Urban Development Company'}, 'officialTitle': 'Randomized, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet Following a 50 mg Dose in Healthy Subjects Under Fed Conditions', 'orgStudyIdInfo': {'id': '50014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bicalutamide 50 mg Tablet', 'description': 'Bicalutamide 50 mg Tablet', 'interventionNames': ['Drug: Bicalutamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Casodex® 50 mg Tablet', 'description': 'Casodex® 50 mg Tablet', 'interventionNames': ['Drug: Bicalutamide']}], 'interventions': [{'name': 'Bicalutamide', 'type': 'DRUG', 'otherNames': ['Casodex®'], 'description': '50 mg Oral Tablet', 'armGroupLabels': ['Bicalutamide 50 mg Tablet', 'Casodex® 50 mg Tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 2K8', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'SFBC Anapharm', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}], 'overallOfficials': [{'name': 'Benoit Girard, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SFBC Anapharm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kremers Urban Development Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Watson Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Benoit Girard, M.D.', 'oldOrganization': 'SFBC Anapharm'}}}}