protocolSection identificationModule nctId: NCT06315283, orgStudyIdInfo id: TV44749-BA-10196, secondaryIdInfos id: 2023-505664-11-00, type: REGISTRY, domain: CTIS, briefTitle: An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Teva Branded Pharmaceutical Products R&D, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.A secondary objective of this trial is to evaluate the safety and tolerability of multiple doses of TV-44749 administered sc in participants with schizophrenia.Another secondary objective of this trial is to compare additional pharmacokinetic parameters of TV-44749 administered sc with oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.The total duration of participation in the trial for each participant is planned to be approximately 21 weeks., conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: TV-44749, interventions name: Oral olanzapine, outcomesModule primaryOutcomes measure: Area under the curve (AUC) of TV-44749, primaryOutcomes measure: AUC of oral olanzapine, secondaryOutcomes measure: Number of participants with at least one treatment-emergent adverse event during treatment with TV-44749, secondaryOutcomes measure: Number of participants with at least one treatment-emergent serious adverse event during treatment with TV-44749, secondaryOutcomes measure: Number of participants with at least one injection site adverse event during treatment with TV-44749, secondaryOutcomes measure: Maximum observed plasma drug concentration at steady state (Cmax,ss) of TV-44749, secondaryOutcomes measure: Minimum observed plasma drug concentration at steady state (Cmin,ss) of TV-44749, secondaryOutcomes measure: Cmax,ss of oral olanzapine, secondaryOutcomes measure: Cmin,ss of oral olanzapine, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Teva Investigational Site 15739, status: RECRUITING, city: Los Alamitos, state: California, zip: 90720, country: United States, geoPoint lat: 33.80307, lon: -118.07256, locations facility: Teva Investigational Site 15740, status: RECRUITING, city: Torrance, state: California, zip: 90504, country: United States, geoPoint lat: 33.83585, lon: -118.34063, locations facility: Teva Investigational Site 15738, status: RECRUITING, city: Hollywood, state: Florida, zip: 33024, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Teva Investigational Site 15741, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30308, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Teva Investigational Site 15742, status: RECRUITING, city: Decatur, state: Georgia, zip: 30030, country: United States, geoPoint lat: 33.77483, lon: -84.29631, locations facility: Teva Investigational Site 15737, status: RECRUITING, city: Marlton, state: New Jersey, zip: 08053, country: United States, geoPoint lat: 39.89122, lon: -74.92183, hasResults: False