Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-26 @ 4:31 PM
Study NCT ID:
NCT01256151
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2010-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000525', 'term': 'Alprazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2010-12-06', 'studyFirstSubmitQcDate': '2010-12-06', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve (AUC) from time zero to last measurable time of alprazolam', 'timeFrame': '72 hours'}, {'measure': 'Peak concentration of alprazolam', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Area under the curve from time zero to infinity', 'timeFrame': '72 hours'}, {'measure': 'AUC% extrapolated', 'timeFrame': '72 hours'}, {'measure': 'Time of Cmax', 'timeFrame': '72 hours'}, {'measure': 'half-life of alprazolam', 'timeFrame': '72 hours'}, {'measure': 'Clinically significant safety laboratory tests', 'timeFrame': 'Screening, Day 0, Day 4'}, {'measure': 'Clincally significant vital signs', 'timeFrame': 'Screening, Day 4'}, {'measure': 'Clinically significant adverse events', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'sublingual', 'alprazolam', 'pharmacokinetics'], 'conditions': ['Anxiety Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6131024&StudyName=Pharmacokinetics%20Of%20Alprazolam%20Sublingual%20Tablet%20Versus%20Conventional%20Tablet', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant abnormalities\n* Positive drug screen, excessive alcohol and tobacco use'}, 'identificationModule': {'nctId': 'NCT01256151', 'briefTitle': 'Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Open-label, Randomized, Single-Dose, 2 Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet', 'orgStudyIdInfo': {'id': 'A6131024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alprazolam conventional tablet', 'description': 'Alprazolam conventional tablet', 'interventionNames': ['Drug: Alprazolam tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Alprazolam sublingual tablet', 'description': 'Alprazolam sublingual tablet', 'interventionNames': ['Drug: Alprazolam sublingual']}], 'interventions': [{'name': 'Alprazolam tablet', 'type': 'DRUG', 'description': '1 mg single dose of alprazolam conventional tablet', 'armGroupLabels': ['Alprazolam conventional tablet']}, {'name': 'Alprazolam sublingual', 'type': 'DRUG', 'description': '1 mg single dose of alprazolam sublingual tablet', 'armGroupLabels': ['Alprazolam sublingual tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], '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': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}