Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-03-05 @ 2:52 AM
Study NCT ID:
NCT02178059
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2014-06-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Goran.Eckerwall@astrazeneca.com', 'phone': '1-800-236-9933', 'title': 'Göran Eckerwall, Medical Science Director', 'organization': 'AstraZeneca R&D'}, 'certainAgreement': {'otherDetails': 'If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and AstraZeneca.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bricanyl Turbuhaler M3', 'description': 'Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation', 'otherNumAtRisk': 34, 'otherNumAffected': 12, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bricanyl Turbuhaler M2', 'description': 'Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation', 'otherNumAtRisk': 33, 'otherNumAffected': 11, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bricanyl Turbuhaler M3', 'description': 'Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation'}, {'id': 'OG001', 'title': 'Bricanyl Turbuhaler M2', 'description': 'Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '89.04', 'groupId': 'OG000', 'lowerLimit': '80.84', 'upperLimit': '98.07'}, {'value': '100.9', 'groupId': 'OG001', 'lowerLimit': '91.54', 'upperLimit': '111.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '88.20', 'ciLowerLimit': '81.03', 'ciUpperLimit': '96.02', 'estimateComment': 'Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)', 'groupDescription': 'No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \\<1.25 provided that the true mean ratios are \\<1.05.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bricanyl Turbuhaler M3', 'description': 'Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation'}, {'id': 'OG001', 'title': 'Bricanyl Turbuhaler M2', 'description': 'Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000', 'lowerLimit': '1.33', 'upperLimit': '1.67'}, {'value': '1.33', 'groupId': 'OG001', 'lowerLimit': '1.33', 'upperLimit': '1.67'}]}]}], 'analyses': [{'pValue': '0.8052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.00', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.17', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period', 'unitOfMeasure': 'hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bricanyl Turbuhaler M3', 'description': 'Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation'}, {'id': 'OG001', 'title': 'Bricanyl Turbuhaler M2', 'description': 'Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '96.63', 'groupId': 'OG000', 'lowerLimit': '87.68', 'upperLimit': '106.5'}, {'value': '109.7', 'groupId': 'OG001', 'lowerLimit': '99.43', 'upperLimit': '121.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bricanyl Turbuhaler M3', 'description': 'Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation'}, {'id': 'OG001', 'title': 'Bricanyl Turbuhaler M2', 'description': 'Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '89.0', 'spread': '29.5', 'groupId': 'OG000'}, {'value': '101', 'spread': '27.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bricanyl Turbuhaler M3', 'description': 'Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation'}, {'id': 'OG001', 'title': 'Bricanyl Turbuhaler M2', 'description': 'Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '10.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bricanyl Turbuhaler M3', 'description': 'Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation'}, {'id': 'OG001', 'title': 'Bricanyl Turbuhaler M2', 'description': 'Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '10.73', 'upperLimit': '13.40'}, {'value': '13.12', 'groupId': 'OG001', 'lowerLimit': '11.73', 'upperLimit': '14.67'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '91.44', 'ciLowerLimit': '84.82', 'ciUpperLimit': '98.58', 'estimateComment': 'Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)', 'groupDescription': 'No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \\<1.25 provided that the true mean ratios are \\<1.05.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'M3 First, Then M2', 'description': 'Sequence 1: M3 first then M2'}, {'id': 'FG001', 'title': 'M2 First, Then M3', 'description': 'Sequence 2: M2 first, then M3'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a single centre study conducted in the UK.', 'preAssignmentDetails': 'Healthy subjects were assessed for eligibility at a screening visit (Visit 1) within 28 days of administration of the first dose of terbutaline via Bricanyl Turbuhaler M2 or Bricanyl Turbuhaler M3 (Visit 2). Subjects were randomly assigned to 1 of 2 treatment sequences: M3 then M2 or M2 then M3'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized Subjects', 'description': 'All randomized subjects'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2014-06-27', 'resultsFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2014-06-27', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-21', 'studyFirstPostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period'}, {'measure': 'Terminal Half-life (t1/2)', 'timeFrame': 'Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose', 'description': 'These will be taken at each treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy volunteers, pharmacokinetic, inhalation'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via current version of Turbuhaler with inhalation via a new version', 'detailedDescription': 'An Open-label, Single-dose, 2-period Cross over Study in Healthy Male and Female Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg after Inhalation via the M3 Turbuhaler (New Version) Compared with the M2 Turbuhaler (Current Version)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female and male volunteers aged between 18 and 65 years, both inclusive\n2. Healthy as judged by the Principal Investigator after medical history, physical examination, 12-lead ECG, laboratory tests (including HIV, HBsAg and hepatitis C antibody tests) and assessments of pulse rate and blood pressure\n3. Ability to use a Turbuhaler according to the provided instructions, as judged by the Principal Investigator or the study nurse\n4. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg -\n\nExclusion Criteria:\n\n1. History or presence of respiratory, gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs (except for cholecystectomy)\n2. Current smokers or those who have smoked or used nicotine products within the previous 3 months should be excluded\n3. Plasma donation within 1 month of screening or any blood donation or blood loss of more than 500 mL during the 3 months prior to screening\n4. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Principal Investigator or history of hypersensitivity to terbutaline (or drugs of a similar chemical structure or class) or inhaled lactose\n5. Positive screen for drugs of abuse and/or alcohol and/or cotinine at screening (Visit 1) or on admission to the study centre (Day -1) prior to administration of the investigational medical product (IMP) on Day 1 -'}, 'identificationModule': {'nctId': 'NCT02178059', 'briefTitle': 'Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-label, Single-dose, 2-period Cross Over Study in Healthy Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg After Inhalation Via the M3 Turbuhaler Compared With the M2 Turbuhaler', 'orgStudyIdInfo': {'id': 'D4711C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bricanyl Turbuhaler M3', 'description': '0.4 mg terbutaline sulphate (delivered dose) per inhalation', 'interventionNames': ['Drug: terbutaline sulphate delivered dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bricanyl Turbuhaler M2', 'description': '0.5 mg terbutaline sulphate (metered dose) per inhalation', 'interventionNames': ['Drug: terbutaline sulphate metered dose']}], 'interventions': [{'name': 'terbutaline sulphate delivered dose', 'type': 'DRUG', 'otherNames': ['Turbuhaler New Version'], 'description': '0.4 mg terbutaline sulphate (delivered dose) per inhalation', 'armGroupLabels': ['Bricanyl Turbuhaler M3']}, {'name': 'terbutaline sulphate metered dose', 'type': 'DRUG', 'otherNames': ['Turbuhaler Current Version'], 'description': '0.5 mg terbutaline sulphate (metered dose) per inhalation', 'armGroupLabels': ['Bricanyl Turbuhaler M2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Amitava Ganguli, MB ChB, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles London United Kingdom'}, {'name': 'Göran Eckervall, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astrazeneca Mölndal, Sweden'}, {'name': 'Ola Beckman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Astrazeneca Mölndal, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}