Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT01285505
Status:
WITHDRAWN
Last Update Posted:
2021-01-28
First Post:
2011-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2011-01-26', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC)', 'timeFrame': '11 days'}, {'measure': 'Alprazolam bioavailability as assessed by peak concentration (Cmax)', 'timeFrame': '11 days'}], 'secondaryOutcomes': [{'measure': 'Alprazolam time of maximum concentration (Tmax)', 'timeFrame': '11 days'}, {'measure': 'Half life of alprazolam', 'timeFrame': '11 days'}, {'measure': 'Clinically significant safety laboratory tests', 'timeFrame': '11 days'}, {'measure': 'Clinically significant adverse events', 'timeFrame': '11 days'}, {'measure': 'Clinically significant vital signs', 'timeFrame': '11 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['alprazolam', 'sublingual', 'bioequivalence'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6131020&StudyName=Bioequivalence%20of%20a%20new%20and%20a%20commercial%20alprazolam%20sublingual%20formulation', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male or female subjects\n* BMI 18 to 26.9\n* must give informed consent\n\nExclusion Criteria:\n\n* clinically significant disease\n* narrow angle glaucoma\n* positive drug screen'}, 'identificationModule': {'nctId': 'NCT01285505', 'briefTitle': 'Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet', 'orgStudyIdInfo': {'id': 'A6131020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alprazolam commercial sublingual tablet', 'interventionNames': ['Drug: alprazolam commercial sublingual formulation']}, {'type': 'EXPERIMENTAL', 'label': 'Alprazolam test sublingual tablet', 'interventionNames': ['Drug: alprazolam test sublingual tablet']}], 'interventions': [{'name': 'alprazolam commercial sublingual formulation', 'type': 'DRUG', 'description': '0.5 mg tablet, single dose', 'armGroupLabels': ['Alprazolam commercial sublingual tablet']}, {'name': 'alprazolam test sublingual tablet', 'type': 'DRUG', 'description': '0.5 mg tablet, single dose', 'armGroupLabels': ['Alprazolam test sublingual tablet']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}