Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-02-01 @ 9:34 AM
Study NCT ID:
NCT02604992
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2015-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-18', 'studyFirstSubmitDate': '2015-11-12', 'studyFirstSubmitQcDate': '2015-11-13', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve from time 0 to the last measured concentration', 'timeFrame': '0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.'}, {'measure': 'Area under the curve extrapolated to infinity', 'timeFrame': '0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.'}, {'measure': 'Maximum plasma concentration', 'timeFrame': '0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.'}, {'measure': 'Time to reach maximum plasma concentration', 'timeFrame': '0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.'}, {'measure': 'Elimination rate constant', 'timeFrame': '0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.'}, {'measure': 'The time prior to the first measurable (non-zero) concentration', 'timeFrame': '0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.'}, {'measure': 'Elimination half-life', 'timeFrame': '0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.'}, {'measure': 'Apparent oral clearance', 'timeFrame': '0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.'}, {'measure': 'Volume of distribution', 'timeFrame': '0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Comparative Bioavailability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions.\n\nThe secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets protocol-specified criteria for qualification\n* Fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator\n\nExclusion Criteria:\n\n* History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters\n* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:\n\n 1. the safety or well-being of the participant or study staff\n 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)\n 3. the analysis of results"}, 'identificationModule': {'nctId': 'NCT02604992', 'briefTitle': 'Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'INSYS Therapeutics Inc'}, 'officialTitle': 'An Open-Label, Randomized, Single-Dose, Two-Period, Two-Way Crossover Comparative Bioavailability Study of Dronabinol Oral Solution, 4.25 mg to Marinol Capsule, 5 mg in Healthy Volunteers Under Fed Conditions', 'orgStudyIdInfo': {'id': 'INS004-15-059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (A,B,C)', 'description': 'With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (B,C,A)', 'description': 'With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (C,A,B)', 'description': 'With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 (C,B,A)', 'description': 'With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5 (A,C,B)', 'description': 'With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6 (B,A,C)', 'description': 'With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}], 'interventions': [{'name': 'Treatment A', 'type': 'DRUG', 'description': 'Dronabinol oral solution, under fed conditions', 'armGroupLabels': ['Group 1 (A,B,C)', 'Group 2 (B,C,A)', 'Group 3 (C,A,B)', 'Group 4 (C,B,A)', 'Group 5 (A,C,B)', 'Group 6 (B,A,C)']}, {'name': 'Treatment B', 'type': 'DRUG', 'otherNames': ['Marinol'], 'description': 'Dronabinol oral capsule, under fed conditions', 'armGroupLabels': ['Group 1 (A,B,C)', 'Group 2 (B,C,A)', 'Group 3 (C,A,B)', 'Group 4 (C,B,A)', 'Group 5 (A,C,B)', 'Group 6 (B,A,C)']}, {'name': 'Treatment C', 'type': 'DRUG', 'otherNames': ['Marinol'], 'description': 'Dronabinol oral capsule, under fasted conditions', 'armGroupLabels': ['Group 1 (A,B,C)', 'Group 2 (B,C,A)', 'Group 3 (C,A,B)', 'Group 4 (C,B,A)', 'Group 5 (A,C,B)', 'Group 6 (B,A,C)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Worldwide Clinical Trials Early Phase Services, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Neha Parikh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'INSYS Therapeutics Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'INSYS Therapeutics Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}