Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-05 @ 12:38 PM
Study NCT ID:
NCT02806869
Status:
COMPLETED
Last Update Posted:
2017-12-08
First Post:
2016-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'duxins@med.umich.edu', 'phone': '734-615-8740', 'title': 'Dr. Duxin Sun', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The variability associated with concentration-time profile in the gastrointestinal tract could not be associated with participant specific factors given the small study sample size.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm #1 - Fasting State, 2 Study Visits', 'description': '1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm #2 - Fed State, 2 Study Visits', 'description': '1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red', 'otherNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Duodenal Fluid pH in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm #1 - Fasting State, 2 Study Visits', 'description': '1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red'}, {'id': 'OG001', 'title': 'Arm #2 - Fed State, 2 Study Visits', 'description': '1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red'}], 'classes': [{'categories': [{'measurements': [{'value': '5.12', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '5.36', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from time 0 to 7 hours', 'description': 'The pH of duodenal fluid was measured at multiple timepoints over a 7 hour period. The reported value represents the mean and standard deviation of duodenal fluid pH.', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Number of Participants Analyzed equals the number of participants who completed the First intervention plus the number of participants who completed the Second Intervention. For Arm #1: Overall Number of Participants Analyzed=13+7=20. For Arm #2: Overall Number of Participants Analyzed=12+5=17.'}, {'type': 'SECONDARY', 'title': 'Maximum Duodenal Fluid Concentration of Ibuprofen in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm #1 - Fasting State, 2 Study Visits', 'description': '1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red'}, {'id': 'OG001', 'title': 'Arm #2 - Fed State, 2 Study Visits', 'description': '1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red'}], 'classes': [{'categories': [{'measurements': [{'value': '217', 'spread': '230', 'groupId': 'OG000'}, {'value': '155', 'spread': '172', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from time 0 to 7 hours', 'description': 'The concentration of duodenal fluid was measured at multiple timepoints over a 7 hour period. The reported value represents the mean and standard deviation maximum concentration measured in duodenal fluid.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Number of Participants Analyzed equals the number of participants who completed the First intervention plus the number of participants who completed the Second Intervention. For Arm #1: Overall Number of Participants Analyzed=13+7=20. For Arm #2: Overall Number of Participants Analyzed=12+5=17.'}, {'type': 'SECONDARY', 'title': 'Average Area Under the Plasma Concentration-time Curve (AUC) in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm #1 - Fasting State, 2 Study Visits', 'description': '1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red'}, {'id': 'OG001', 'title': 'Arm #2 - Fed State, 2 Study Visits', 'description': '1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red'}], 'classes': [{'categories': [{'measurements': [{'value': '242', 'spread': '88.9', 'groupId': 'OG000'}, {'value': '229', 'spread': '76.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from time 0 to 24 hours', 'description': 'The plasma concentration of ibuprofen was measured at multiple timepoints over a 24 hour period. The reported value represents the mean and standard deviation of AUC over this time frame.', 'unitOfMeasure': 'h*mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Number of Participants Analyzed equals the number of participants who completed the First intervention plus the number of participants who completed the Second Intervention. For Arm #1: Overall Number of Participants Analyzed=13+7=20. For Arm #2: Overall Number of Participants Analyzed=12+5=17.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm #1 - Fasting State, 2 Study Visits', 'description': '1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red'}, {'id': 'FG001', 'title': 'Arm #2 - Fed State, 2 Study Visits', 'description': '1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red'}], 'periods': [{'title': 'First Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}, {'title': 'Washout (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm #1 - Fasting State, 2 Study Visits', 'description': '1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red'}, {'id': 'BG001', 'title': 'Arm #2 - Fed State, 2 Study Visits', 'description': '1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '31.6', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '30.4', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', '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': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', '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', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'spread': '4.65', 'groupId': 'BG000'}, {'value': '26.2', 'spread': '4.61', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '4.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Overall Number of Baseline Participants equals the number of participants who completed the First intervention'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a parallel study design that allocated subjects into a fasted or fed group. Subject were asked to complete the same study procedures on two occasions.\n\nSubjects assigned to the fasted or fed group were not crossed-over from one group to the other.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-03', 'studyFirstSubmitDate': '2016-05-13', 'resultsFirstSubmitDate': '2017-07-23', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-03', 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Duodenal Fluid pH in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen', 'timeFrame': 'from time 0 to 7 hours', 'description': 'The pH of duodenal fluid was measured at multiple timepoints over a 7 hour period. The reported value represents the mean and standard deviation of duodenal fluid pH.'}], 'secondaryOutcomes': [{'measure': 'Maximum Duodenal Fluid Concentration of Ibuprofen in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen', 'timeFrame': 'from time 0 to 7 hours', 'description': 'The concentration of duodenal fluid was measured at multiple timepoints over a 7 hour period. The reported value represents the mean and standard deviation maximum concentration measured in duodenal fluid.'}, {'measure': 'Average Area Under the Plasma Concentration-time Curve (AUC) in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen', 'timeFrame': 'from time 0 to 24 hours', 'description': 'The plasma concentration of ibuprofen was measured at multiple timepoints over a 24 hour period. The reported value represents the mean and standard deviation of AUC over this time frame.'}]}, 'conditionsModule': {'conditions': ['Human Gastrointestinal Physiology Data']}, 'referencesModule': {'references': [{'pmid': '28980204', 'type': 'DERIVED', 'citation': 'Yu A, Jackson T, Tsume Y, Koenigsknecht M, Wysocki J, Marciani L, Amidon GL, Frances A, Baker JR, Hasler W, Wen B, Pai A, Sun D. Mechanistic Fluid Transport Model to Estimate Gastrointestinal Fluid Volume and Its Dynamic Change Over Time. AAPS J. 2017 Nov;19(6):1682-1690. doi: 10.1208/s12248-017-0145-x. Epub 2017 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The purpose of this clinical study was to evaluate the in vivo drug dissolution and systemic absorption of the BCS Class IIa drug ibuprofen under fed and fasted conditions by direct sampling of stomach and small intestinal luminal content. Expanding current knowledge of drug dissolution in vivo will help to establish physiologically relevant in vitro models predictive of drug dissolution.', 'detailedDescription': 'This is an in vivo study designed to acquire human gastrointestinal (GI) physiology data from healthy subjects under fasting and fed conditions which are necessary for mechanistic absorption model development. Each subject will be asked to complete two GI tube insertion procedures. Subjects will complete this study twice under the same conditions of the GI tract, either fasting state or fed state, in order to provide intra-subject variability. A minimum of 7 days will separate each GI tube insertion procedure. The objectives of this study are, as follows: Objective #1: To acquire human GI physiology data including GI motility, pH of GI fluids, and GI fluid volume under fasting and fed conditions; Objective #2: To measure drug concentration and calculate drug dissolution in the GI tract in vivo under fasting and fed conditions; Objective #3: To monitor plasma drug concentration and evaluate pharmacokinetics of administered drug during GI tube insertion studies under fasting and fed conditions. These in vivo results will be used to validate in vitro dissolution methods and to support computational and mathematical modeling efforts, in order to develop an oral drug product optimization process that may be applied to future drugs to maximize oral drug safety and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults age 18 to 55.\n2. Male or female voluntarily able to give informed consent.\n\nExclusion Criteria:\n\n1. Adults unable to consent for themselves or mentally incapacitated.\n2. Prisoners.\n3. Significant clinical illness within 3 weeks prior to Screening.\n4. Use of concomitant medications within 2 weeks prior to receiving study drug, including but not limited to prescription drugs, herbal and dietary supplements, over the counter medications, and vitamins. Birth control is permitted.\n5. Received an investigational drug within 60 days prior to receiving the study drug.\n6. History of gastrointestinal surgery.\n7. Surgery within the past 3 months.\n8. History of allergy to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs).\n9. History of severe allergic diseases including drug allergies, with the exception of seasonal allergies.\n10. Any other factor, condition, or disease, including, but not limited to, cardiovascular, renal, hepatic, or gastrointestinal disorders that may, in the opinion of the Investigator, jeopardize the safety of the patient or impact the validity of the study results.\n11. History of drug addiction or alcohol abuse within the past 12 months.\n12. Pregnant or lactating females.\n13. Any clinically significant abnormal lab values during Screening.'}, 'identificationModule': {'nctId': 'NCT02806869', 'briefTitle': 'Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment: A Research Study to Evaluate the Performance of an Ibuprofen Oral Dosage Form in the Gastrointestinal Tract of Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'FDA_13-RFQ-1116088'}, 'secondaryIdInfos': [{'id': 'HHSF223201310144C', 'type': 'OTHER_GRANT', 'domain': 'U.S. Food and Drug Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm #1 - Fasting State, 2 study visits', 'description': '1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red', 'interventionNames': ['Drug: Single dose of ibuprofen (800 mg tablet)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm #2 - Fed State, 2 study visits', 'description': '1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red\n2. Washout period of at least 7 days\n3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red', 'interventionNames': ['Drug: Single dose of ibuprofen (800 mg tablet)', 'Dietary Supplement: Pulmocare, two 8.0 oz (236.6 mL) cans']}], 'interventions': [{'name': 'Single dose of ibuprofen (800 mg tablet)', 'type': 'DRUG', 'armGroupLabels': ['Arm #1 - Fasting State, 2 study visits', 'Arm #2 - Fed State, 2 study visits']}, {'name': 'Pulmocare, two 8.0 oz (236.6 mL) cans', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Arm #2 - Fed State, 2 study visits']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Duxin Sun, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Food and Drug Administration (FDA)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Duxin Sun', 'investigatorAffiliation': 'University of Michigan'}}}}