Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 7:17 AM
Study NCT ID:
NCT01570959
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2012-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2012-03-28', 'studyFirstSubmitQcDate': '2012-04-02', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bioequivalence determined by statistical comparison Cmax', 'timeFrame': '10 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar I Disorder']}, 'descriptionModule': {'briefSummary': "The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Stable patients with the DSM-IV TR diagnosis of schizophrenia. These patients are to be identified via psychiatric evaluation and meet DSM-IV TR criteria for schizophrenia of paranoid (295.30), disorganized (295.10), catatonic (295.20), undifferentiated (295.90), or residual (295.60) subtype.\n2. Patient to have no significant breakthrough symptoms or exacerbations of psychiatric illness necessitating hospitalization in the 3 months prior to screening.\n3. Patient to have a CGI-S score of 3 or less at screening.\n4. On a stable regimen of treatment to include quetiapine fumarate for 3 months minimum prior to screening, and on a dose of quetiapine fumarate totaling 600 mg total per day for a minimum of 1 month prior to screening. Patients who are on qd dosing of daily quetiapine fumarate must be willing to convert to 300 mg bid dosing for the duration of the study.\n\nExclusion Criteria:\n\n1. All other DSM-IV axis I diagnoses, including schizoaffective disorder, schizophreniform disorder and/or any other psychiatric diagnoses that in the opinion of the principal investigator may during the conduct of the trial become a primary treatment concern, or may interfere in the patients ability to participate in the trial.\n2. Positive test for HIV, Hepatitis B, or Hepatitis C.\n3. Treatment with known enzyme altering drugs.\n4. History of allergic or adverse response to quetiapine or any comparable or similar product.'}, 'identificationModule': {'nctId': 'NCT01570959', 'briefTitle': 'Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'West-Ward Pharmaceutical'}, 'officialTitle': 'A Two Period, Two Treatment, Two Way, Steady State Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'QUET-T300-PVSS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Quetiapine Fumarate', 'type': 'DRUG', 'otherNames': ['Seroquel'], 'description': '300 mg tablet'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, Inc.', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Clinical Research Center', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Segal Institute for Clinical Research', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Global Medical Institutes/Princeton Medical Institute', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '08046', 'city': 'Willingboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CRI Worldwide', 'geoPoint': {'lat': 40.02789, 'lon': -74.86905}}, {'zip': '78754', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Community Clinical Research, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Claghorn-Lesem Research Clinic, Ltd', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roxane Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}