Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT01322867
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2011-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2011-03-23', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug', 'timeFrame': 'Up to 72h'}, {'measure': 'Area under the plasma concentration versus time curve from time zero to the last measurable concentration of Test Drug and Reference Drug (AUC(0-tlast))', 'timeFrame': 'Up to 72h'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve from time zero to infinity of Test Drug and Reference Drug (AUC(0-inf))', 'timeFrame': 'Up to 72h'}, {'measure': 'Time to peak concentration of Test Drug and Reference Drug (Tmax)', 'timeFrame': 'Up to 72h'}, {'measure': 'Half-life of Test Drug and Reference Drug (T1/2)', 'timeFrame': 'Up to 72h'}, {'measure': 'Elimination rate constant (K el)', 'timeFrame': 'Up to 72h'}, {'measure': 'Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity', 'timeFrame': 'Up to 72h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioequivalence study', 'alprazolam', 'frontal'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6131023&StudyName=A%20Bioequivalence%20Study%20Of%20A%20New%20Alprazolam%20Dropped%20Formulation%20Versus%20Alprazolam%20Tablets', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.'}, '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 (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)\n* The BMI - Body Mass Index of the volunteers should be within the range of 18,5 to 24,9 (Dietary Guidelines for Americans) and it may vary up to 15% due to the upper limit (18,5 to 28,63) and total body weight \\>50kg\n* An informed consent document signed and dated by the subject or a legally acceptable representative. If the subject and/or legally acceptable representative cannot read, then the informed consent document may be signed by an impartial witness\n* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption (eg, gastrectomy)\n* A history of suicidal thoughts, behavior or suicide attempts\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)\n* Known hypersensitivity to alprazolam or any components of the product\n* History of sensitivity to heparin or heparin-induced thrombocytopenia\n* A positive bHCG exam for women\n* Subjects with myasthenia gravis or acute narrow angle glaucoma'}, 'identificationModule': {'nctId': 'NCT01322867', 'briefTitle': 'A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.', 'orgStudyIdInfo': {'id': 'A6131023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Drug', 'interventionNames': ['Drug: alprazolam tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test Drug', 'interventionNames': ['Drug: alprazolam oral solution']}], 'interventions': [{'name': 'alprazolam tablet', 'type': 'DRUG', 'description': '0,25 mg oral tablets given once', 'armGroupLabels': ['Reference Drug']}, {'name': 'alprazolam oral solution', 'type': 'DRUG', 'description': '0,75 mg/ml Oral Solution (Drops) given once', 'armGroupLabels': ['Test Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74935-530', 'city': 'Aparecida de Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'ICF - Instituto de Ciencias Farmaceuticas', 'geoPoint': {'lat': -16.82333, 'lon': -49.24389}}], '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'}}}}