Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 5:23 AM
Study NCT ID:
NCT01220167
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2010-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DrugInfo@strativapharma.com', 'phone': '800-828-9393', 'title': 'Medical Affairs', 'organization': 'Par Pharmaceutical'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the time of the first dose until 30 days following the last dose (overall approximately 1.5 months for each subject). No adverse events were reported during the study and follow-up period. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study). Thus, abnormal laboratory analytes reported as adverse events could not be attributed to any of the 3 study treatments.', 'description': 'All adverse events (AE) were recorded from the time of the first dose until the last follow-up visit scheduled 48 hours following the last dose of study intervention. Serious adverse events (SAEs) were reported from the time of the first dose until 30 days following the last dose.\n\nSubjects with AEs considered related to study drug and any SAE regardless of causality were followed until resolution of the event or the subject was lost to follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'ODFS 8 mg With and Without Water and Zofran ODT Without Water', 'description': 'Single dose of ondansetron ODFS 8 mg film administered with and without water and Zofran 8 mg administered without water in randomized sequence.\n\nClinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study). Thus, abnormal laboratory analytes reported as adverse events could not be attributed to any of the 3 study treatments.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Alanine aminotransferase increase', 'notes': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'notes': 'AST increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood count increased', 'notes': 'WBC count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ondansetron ODFS With or Without Water and Zofran ODT', 'description': 'Single dose of Ondansetron ODFS 8 mg film administered with and then without water and Zofran 8 mg administered without water'}], 'classes': [{'title': 'ODFS without water', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.866', 'spread': '13.3089', 'groupId': 'OG000'}]}]}, {'title': 'ODFS with water', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.843', 'spread': '15.9103', 'groupId': 'OG000'}]}]}, {'title': 'Zofran ODT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.382', 'spread': '12.3572', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose', 'description': 'Maximum Plasma Concentration (Time to reach maximum concentration)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '18 subjects were enrolled. One subject did not complete.'}, {'type': 'PRIMARY', 'title': 'AUCt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ondansetron ODFS With and Without Water and Zofran ODT', 'description': 'Single dose of Ondansetron ODFS 8 mg film with and again without water and Zofran 8 mg without water'}], 'classes': [{'title': 'ODFS without water', 'categories': [{'measurements': [{'value': '290.687', 'spread': '106.5203', 'groupId': 'OG000'}]}]}, {'title': 'ODFS with water', 'categories': [{'measurements': [{'value': '291.069', 'spread': '99.5911', 'groupId': 'OG000'}]}]}, {'title': 'Zofran ODT', 'categories': [{'measurements': [{'value': '285.457', 'spread': '105.3048', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose', 'description': 'Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose")', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '18 healthy subjects were enrolled. Only 17 subjects completed the study. 0 to 96 hours post-dose'}, {'type': 'PRIMARY', 'title': 'AUCinf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ondansetron ODFS With and Without Water and Zofran ODT', 'description': 'Single dose of Ondansetron ODFS 8 mg film with water and without water and Zofran 8 mg without water'}], 'classes': [{'title': 'ODFS without water', 'categories': [{'measurements': [{'value': '311.349', 'spread': '119.7910', 'groupId': 'OG000'}]}]}, {'title': 'ODFS with water', 'categories': [{'measurements': [{'value': '310.394', 'spread': '112.7499', 'groupId': 'OG000'}]}]}, {'title': 'Zofran ODT', 'categories': [{'measurements': [{'value': '306.497', 'spread': '121.8256', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose', 'description': 'Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '18 subject were enrolled. Only 17 completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence ABC', 'description': 'Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water).'}, {'id': 'FG001', 'title': 'Sequence BCA', 'description': 'Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water).'}, {'id': 'FG002', 'title': 'Sequence CAB', 'description': 'Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water).'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Urine positive for substance abuse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Fifty-five healthy adult volunteers were screened for study eligibility between 18 Aug 2008 and 21 Aug 2008 at VIMTA VHS Research Centre in Adyar, Chennai - 600 113, India.', 'preAssignmentDetails': 'Eighteen of 55 subjects were randomized. Of those not randomized, 29 did not meet eligibility criteria and 6 declined to participate. The 18 eligible participants reported to the study site on 22 Aug 2008, 25 Aug 2008 and 28 Aug 2008 for Period 1, Period 2, \\& Period 3, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence ABC', 'description': 'Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water).'}, {'id': 'BG001', 'title': 'Sequence BCA', 'description': 'Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water).'}, {'id': 'BG002', 'title': 'Sequence CAB', 'description': 'Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '27.6', 'spread': '7.57', 'groupId': 'BG000'}, {'value': '31.1', 'spread': '8.27', 'groupId': 'BG001'}, {'value': '28.8', 'spread': '5.98', 'groupId': 'BG002'}, {'value': '28.2', 'spread': '6.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (kg/m^2', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '0.07', 'groupId': 'BG000'}, {'value': '22.8', 'spread': '0.78', 'groupId': 'BG001'}, {'value': '22.9', 'spread': '1.95', 'groupId': 'BG002'}, {'value': '23.7', 'spread': '0.56', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Open label, balanced, randomized three period, three treatment, three sequence, three-way crossover bioavailability study .'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2010-10-12', 'resultsFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-06', 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose', 'description': 'Maximum Plasma Concentration (Time to reach maximum concentration)'}, {'measure': 'AUCt', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose', 'description': 'Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose")'}, {'measure': 'AUCinf', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose', 'description': 'Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioavailability'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered under fasting conditions without water.', 'detailedDescription': 'This was an open-label, single oral dose,randomized sequence, three-way crossover study to compare the bioavailability, safety and tolerability of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered without (Test Treatment A) and with water (Test Treatment B) with that of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered without water (Reference Treatment C) in healthy adult participants. The 3 treatment sequences were: ABC, BCA, and CAB, in which, all treatments were administered after an overnight fasting of at least 10 hours in each period.\n\nParticipants reported to the study site between 07:30 am to 04:30 pm on 22 Aug 2008, 25 Aug 2008, and 28 Aug 2008 for Period 1, Period 2, \\& Period 3, respectively. Participants were served dinner between 8:00 pm to 8:30 pm, to ensure a minimum of 10 hours of fasting prior to administration of a single dose of either the test or reference product. Participants were dosed as per the randomization schedule with a 3-day wash out period between each administration.\n\nA total of 18 blood samples (4 mL each) were collected from each subject in each period for pharmacokinetic analyses. Safety assessments including monitoring of adverse events, periodic physical examination, and vital signs monitoring. Urine Drug Screening was done at the time of check-in of all the study periods to identify participants with any substance abuse. Urine pregnancy screen (for female subjects only) was scheduled at the time of screening and at admission for Period 1, Period 2, Period 3. A clinical assessment, which included general and systemic examination, was done at the pre-study screening and post study physical examination. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe criteria for inclusion in the study were:\n\n* Study volunteer should provide written informed consent.\n* Study volunteer must be a healthy adult within 18-45 years of age (inclusive).\n* Study volunteer should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.\n* Study volunteer should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.\n* Study volunteer must be of normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.\n* Study volunteer should have a normal ECG, chest X-ray and vital signs.\n* If study volunteer is a female and is of child bearing potential she must be practicing an acceptable method of birth control for the duration of the study.\n\nExclusion Criteria:\n\nThe criteria for exclusion from the study were:\n\n* Study volunteer incapable of understanding the informed consent.\n* Study volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.\n* Study volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.\n* Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma\n* Study volunteer who smokes regularly more than ten cigarettes daily.\n* Study volunteer who has taken over the counter or prescribed medications.\n* Study volunteer with a history of any psychiatric illness, which may impair the ability to provide written, informed consent.'}, 'identificationModule': {'nctId': 'NCT01220167', 'briefTitle': 'Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aquestive Therapeutics'}, 'officialTitle': 'Open-label, Randomized, Three-way Crossover Bioavailability Study Comparing Ondansetron Orally Dissolving Filmstrip (ODFS) With and Without Water to Zofran Orally Dissolving Tablets (ODT) Without Water in Healthy Adult Study Participants', 'orgStudyIdInfo': {'id': 'OND/CR/051/08/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence ABC', 'description': 'Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.', 'interventionNames': ['Drug: Ondansetron 8 mg ODFS without water', 'Drug: Ondansetron 8 mg ODFS with water', 'Drug: Zofran ODT (ondansetron 8 mg) without water']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence BCA', 'description': 'Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.', 'interventionNames': ['Drug: Ondansetron 8 mg ODFS without water', 'Drug: Ondansetron 8 mg ODFS with water', 'Drug: Zofran ODT (ondansetron 8 mg) without water']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence CAB', 'description': 'Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.', 'interventionNames': ['Drug: Ondansetron 8 mg ODFS without water', 'Drug: Ondansetron 8 mg ODFS with water', 'Drug: Zofran ODT (ondansetron 8 mg) without water']}], 'interventions': [{'name': 'Ondansetron 8 mg ODFS without water', 'type': 'DRUG', 'otherNames': ['Test Treatment (A)'], 'description': 'Single dose of Ondansetron 8 mg (ODFS) administered without water', 'armGroupLabels': ['Sequence ABC', 'Sequence BCA', 'Sequence CAB']}, {'name': 'Ondansetron 8 mg ODFS with water', 'type': 'DRUG', 'otherNames': ['Test Treatment (B)'], 'description': 'Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water', 'armGroupLabels': ['Sequence ABC', 'Sequence BCA', 'Sequence CAB']}, {'name': 'Zofran ODT (ondansetron 8 mg) without water', 'type': 'DRUG', 'otherNames': ['Reference Treatment (C)'], 'description': 'Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water', 'armGroupLabels': ['Sequence ABC', 'Sequence BCA', 'Sequence CAB']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sudershan Vishwanath, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vimta Labs Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aquestive Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}