Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-03-09 @ 7:27 AM
Study NCT ID:
NCT02477267
Status:
COMPLETED
Last Update Posted:
2015-09-03
First Post:
2015-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2015-06-18', 'studyFirstSubmitQcDate': '2015-06-19', 'lastUpdatePostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'within 21 days', 'description': 'Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone'}, {'measure': 'Time to Cmax (Tmax)', 'timeFrame': 'within 21 days', 'description': 'Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone'}, {'measure': 'Elimination rate constant', 'timeFrame': 'within 21 days', 'description': 'Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone'}, {'measure': 'Elimination half-life (T½)', 'timeFrame': 'within 21 days', 'description': 'Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone'}, {'measure': 'Area under the curve to the final sample with a concentration greater than the limit of quantification (LOQ [AUClast])', 'timeFrame': 'within 21 days', 'description': 'Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone'}, {'measure': 'Area under the curve extrapolated to infinity (AUCinf)', 'timeFrame': 'within 21 days', 'description': 'Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Opiate Dependence']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets protocol-specified criteria for qualification and contraception\n* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications\n* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures\n\nExclusion Criteria:\n\n* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters\n* Has 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': 'NCT02477267', 'briefTitle': 'Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'INSYS Therapeutics Inc'}, 'officialTitle': 'A Pivotal, Phase 1, Open-Label, Randomized, Crossover, Single-Dose, Comparative Bioavailability Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'INS009-15-033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test-Reference Sequence', 'description': 'SL spray, followed by SL film', 'interventionNames': ['Drug: SL spray', 'Drug: SL film']}, {'type': 'EXPERIMENTAL', 'label': 'Reference-Test Sequence', 'description': 'SL film followed by SL spray', 'interventionNames': ['Drug: SL spray', 'Drug: SL film']}], 'interventions': [{'name': 'SL spray', 'type': 'DRUG', 'otherNames': ['Buprenorphine naloxone sublingual spray'], 'armGroupLabels': ['Reference-Test Sequence', 'Test-Reference Sequence']}, {'name': 'SL film', 'type': 'DRUG', 'otherNames': ['Buprenorphine and naloxone sublingual film'], 'armGroupLabels': ['Reference-Test Sequence', 'Test-Reference Sequence']}]}, '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': 'Giovanni DeCastro', 'role': 'STUDY_DIRECTOR', 'affiliation': 'INSYS Therapeutics Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'INSYS Therapeutics Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}