Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-27 @ 12:20 PM
Study NCT ID:
NCT01380457
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2011-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2011-06-16', 'studyFirstSubmitQcDate': '2011-06-22', 'lastUpdatePostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence', 'description': 'To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioequivalence', 'dronabinol', 'fasting'], 'conditions': ['To Determine Bioequivalence Under Fasting Conditions']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol.', 'detailedDescription': 'To compare the plasma levels of dronabinol (delta-9-tetrahydrocannabinol)and the principle active metabolite 11-OH-delta-9-tetrahydrocannabinol levels produced after administration of the test formulation with those produced after administration of a marketed reference product, under fasted conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers, 18 - 55 years of age\n* Subjects must be within 18 to 29.9 kilograms/m2 per the BMI\n* General good health as determined by medical history and physical examination within 30 days prior to the start of the study\n* Blood chemistry, hematology, and urinalysis tests will be performed within 30 days prior to the start of the study\n* No participation in an investigational drug study or donation of blood within 30 days prior to the start of the study\n* At screening, subjects must have blood pressure and pulse rate within specified ranges\n* No grapefruit juice or grapefruit-containing products for at least 72 hours prior to drug administration, each period. Subjects will be queried at check-in each period on consumption of grapefruit juice or grapefruit containing products. Results will be recorded and reported in the final report.\n* No alcohol consumption for at least 24 hours prior to drug administration, each period\n* No caffeine or xanthine consumption for 48 hours prior prior to drug administration, each period\n* No prescription drugs (excluding hormonal contraceptives) within 14 days prior to drug administration, each period\n* Subjects should refrain from taking OTC preparations, and/or nutritional supplements within 7 days prior to drug administration, each period. Subjects shall refrain from taking herbal remedies within 14 day prior to drug administration, and throughout the study periods\n* Female subjects must not be pregnant or nursing; and must be surgically sterile; one year post-menopausal; or on hormonal contraceptive agents), a diaphragm or condom with spermicidal foam or jelly, or IUD for at least 3 months prior to drug administration and agree to use the same method of contraception for at least 1 month after the last drug administration\n* Negative serum pregnancy test at screening and negative urine pregnancy test prior to drug administration, each period\n* Negative HIV 1, hepatitis B surface antigen, an urine screen for drugs of abuse within 30 days prior to the start of the study\n\nExclusion Criteria:\n\n* Disease or condition that could impact interpretation of study results or a condition which treatment would be contraindicated per currently approved product labeling\n* Subjects had any of the following conditions:\n\n * used any prescription or OTC medication within 14 days of study initiation\n * a positive urine test for illicit drugs\n * participated in a clinical investigation within the past 30 days\n * had clinically significant allergies to drugs or foods, ot\n * any condition that might place them at increased risk of complications'}, 'identificationModule': {'nctId': 'NCT01380457', 'briefTitle': 'Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Par Pharmaceutical, Inc.'}, 'officialTitle': 'A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions', 'orgStudyIdInfo': {'id': '11885'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Subjects received the test formulated product manufactured by Pharmaceutics International, Inc. and marketed by Par Pharmaceutical, Inc. under fasting conditions', 'interventionNames': ['Drug: Dronabinol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Subjects received the reference listed drug manufactured by Banner Pharmacaps, Inc. and marketed by Unimed Pharmaceutical, Inc.', 'interventionNames': ['Drug: Marinol']}], 'interventions': [{'name': 'Dronabinol', 'type': 'DRUG', 'otherNames': ['Marinol'], 'description': 'Capsules, 10 mg, single dose, fasting conditions', 'armGroupLabels': ['A']}, {'name': 'Marinol', 'type': 'DRUG', 'otherNames': ['Dronabinol'], 'description': 'Capsules, 10 mg, single-dose, fasting conditions', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'BASi', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Dilip K Guha-Ray, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BASi Baltimore Clinical Research Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Par Pharmaceutical, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BASi Clinical Research Unit', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Alfred Elvin/Director of Biopharmaceutics', 'oldOrganization': 'Par Pharmaceutical, Inc.'}}}}