Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-22 @ 2:31 PM
Study NCT ID:
NCT01734902
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2012-11-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002086', 'term': 'Butylscopolammonium Bromide'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of trial medication until 7 days after the end of treatment period, upto 9 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Hyoscine Butylbromide Drops (T)', 'description': 'Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Buscopan® Tablet (R)', 'description': 'Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 3, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyoscine Butylbromide Drops (T)', 'description': 'Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.'}, {'id': 'OG001', 'title': 'Buscopan® Tablet (R)', 'description': 'Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'spread': '140.0', 'groupId': 'OG000'}, {'value': '77.1', 'spread': '167.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean ratio T/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.97', 'ciLowerLimit': '74.046', 'ciUpperLimit': '102.151', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '35.6', 'estimateComment': 'Standard error of the mean is actually intra-individual geometric coefficient variance \\[%\\]. Statistical analysis is based on PKS which includes 27 subjects.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': "The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.', 'description': 'Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.', 'unitOfMeasure': 'Picogram/millilitre [pg/mL]', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive statistics is based on treated set (TS) and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyoscine Butylbromide Drops (T)', 'description': 'Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.'}, {'id': 'OG001', 'title': 'Buscopan® Tablet (R)', 'description': 'Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '564.0', 'spread': '131.0', 'groupId': 'OG000'}, {'value': '608.0', 'spread': '139.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean ratio T/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.05', 'ciLowerLimit': '77.26', 'ciUpperLimit': '102.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '31.2', 'estimateComment': 'Standard error of the mean is actually intra-individual geometric coefficient variance \\[%\\]. Statistical analysis is based on PKS which includes 27 subjects.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': "The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.', 'description': 'AUC0-tz, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point', 'unitOfMeasure': 'Picogram*hour/millilitre [pg*h/mL]', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive statistics is based on TS and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyoscine Butylbromide Drops (T)', 'description': 'Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.'}, {'id': 'OG001', 'title': 'Buscopan® Tablet (R)', 'description': 'Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '623.0', 'spread': '122.0', 'groupId': 'OG000'}, {'value': '668.0', 'spread': '125.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean ratio T/R [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '90.03', 'ciLowerLimit': '78.78', 'ciUpperLimit': '102.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '29.3', 'estimateComment': 'Standard error of the mean is actually intra-individual geometric coefficient variance \\[%\\]. Statistical analysis is based on PKS which includes 27 subjects.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': "The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.', 'description': 'AUC0-∞, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity', 'unitOfMeasure': 'Picogram*hour/millilitre [pg*h/mL]', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive statistics is based on TS and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Buscopan® Tablet (R)/Hyoscine Butylbromide Drops (T)', 'description': 'Participants administered orally in the morning on Day 1 of period 1 with single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan®, followed by 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.'}, {'id': 'FG001', 'title': 'Hyoscine Butylbromide Drops (T)/Buscopan® Tablet (R)', 'description': 'Participants administered orally in the morning on Day 1 of period 1 with 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) orally, followed by single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Other than listed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Randomised, single-dose, open-label, two-way crossover trial in healthy volunteers to investigate and compare the relative bioavailability of two formulations of hyoscine butylbromide administered orally as drops (T: test treatment) or as sugar-coated Buscopan® tablets(R: reference treatment).', 'preAssignmentDetails': 'All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be randomized to trial treatment if any one of the specific entry criteria were not met.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Buscopan® Tablet (R)/Hyoscine Butylbromide Drops (T)', 'description': 'Participants administered orally in the morning on Day 1 of period 1 with single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan®, followed by 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.'}, {'id': 'BG001', 'title': 'Hyoscine Butylbromide Drops (T)/Buscopan® Tablet (R)', 'description': 'Participants administered orally in the morning on Day 1 of period 1 with 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) orally, followed by single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity was not captured in this trial.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS) :The TS includes all subjects entered in the trial and treated with at least one dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-22', 'studyFirstSubmitDate': '2012-11-23', 'resultsFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2012-11-23', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-22', 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)', 'timeFrame': 'Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.', 'description': 'Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.'}, {'measure': 'Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': 'Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.', 'description': 'AUC0-tz, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )', 'timeFrame': 'Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.', 'description': 'AUC0-∞, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of the current trial is to establish the bioequivalence of 2 hyoscine butylbromide dose forms following oral administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1\\. Healthy male and female subjects\n\nExclusion criteria:\n\n1\\. Any relevant deviation from healthy conditions'}, 'identificationModule': {'nctId': 'NCT01734902', 'briefTitle': 'Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide, Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Study)', 'orgStudyIdInfo': {'id': '202.846'}, 'secondaryIdInfos': [{'id': '2012-003720-20', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Hyoscine butylbromide', 'description': 'drops, oral administration with 240 mL water', 'interventionNames': ['Drug: Hyoscine butylbromide']}, {'type': 'EXPERIMENTAL', 'label': '2 Hyoscine butylbromide', 'description': 'sugar coated tablets, oral administration with 240 mL water', 'interventionNames': ['Drug: Hyoscine butylbromide']}], 'interventions': [{'name': 'Hyoscine butylbromide', 'type': 'DRUG', 'description': 'sugar coated tablets for oral administration', 'armGroupLabels': ['2 Hyoscine butylbromide']}, {'name': 'Hyoscine butylbromide', 'type': 'DRUG', 'description': 'drops for oral administration', 'armGroupLabels': ['1 Hyoscine butylbromide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ingelheim', 'country': 'Germany', 'facility': '202.846.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.97078, 'lon': 8.05883}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}