[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630890":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":59,"collaborators":36,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":36,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":36,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":36,"overallStatus":40,"whyStopped":36,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test product","ACTIVE_COMPARATOR","Paliperidone Palmitate Injection (3M), 1.75 mL: 350 mg",[13],"Drug: Paliperidone Palmitate Injection (3M)",{"label":15,"type":10,"description":16,"interventionNames":17},"Reference product","Invega Trinza, 1.75 mL: 350 mg",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Paliperidone Palmitate Injection (3M)","Intramuscular injection",[15,9],[25],"SYHF2037",[27],{"name":28,"affiliation":29,"role":30},"Gang Wang, M.D.","Beijing Anding Hospital Capital Medical University","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587",null,"ctr-contact@cspc.cn",[39],{"facility":29,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Beijing","Beijing Municipality","100120","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53,56,57],{"name":28,"role":34,"phone":54,"phoneExt":36,"email":55},"010-58303236","adyyjg@163.com",{"name":28,"role":30,"phone":36,"phoneExt":36,"email":36},{"name":58,"role":30,"phone":36,"phoneExt":36,"email":36},"Anning Li, M.D.",{"type":60,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100630890","a-bioequivalence-study-of-pp3m-in-patients-with-schizophrenia-100630890",false,"NCT07493551","A Bioequivalence Study of PP3M in Patients With Schizophrenia","A Randomized, Open-label, Multicenter, Two-formulation, Multiple-dose, Parallel-design Bioequivalence Study of Paliperidone Palmitate Injection (3M) in Chinese Patients With Schizophrenia","Inclusion Criteria:\n\n* 18 to 65 years old (including 18 and 65 years old).\n* Patients diagnosed with schizophrenia (by ICD-10 criteria) before screening.\n* Weight: male patients with weight ≥50.0 kg, female patients with weight ≥45.0 kg, with the body mass index of 19.0\\~35.0 kg\u002Fm\\^2 (including 19.0 and 35.0).\n* Positive and Negative Syndrome Scale (PANSS) total score lower than 70 at screening and baseline.\n* Clinical Global Impression-Severity (CGI-S) lower than 4 at screening and baseline.\n* Patients and their guardians voluntarily sign the ICF and are able to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Be allergic, or have a clear history of allergies to trial drugs and components.\n* Patients with cardiovascular, liver, kidney, gastrointestinal, psychiatric, or neurological diseases that may affect participation in the trial, as determined by the investigator.\n* History of tardive dyskinesia.","ALL","18 Years","65 Years",{"count":72,"type":73},260,"ESTIMATED","INTERVENTIONAL",[76],"NA","To evaluate the bioequivalence of the test formulation paliperidone palmitate injection (3M) produced by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. and the reference formulation paliperidone palmitate injection (3M) (brand name: Invega Trinza) by Janssen Pharmaceutica N.V. under multiple-dose administration.",[79],"Schizophrenia","2026-03-23",{"date":82,"type":83},"2026-03-25","ACTUAL",{"date":85,"type":83},"2024-10-09",{"date":87,"type":73},"2026-12-31",{"name":5,"class":6},1]