Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:08 PM
Study NCT ID:
NCT07493551
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study of PP3M in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068882', 'term': 'Paliperidone Palmitate'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label, multicenter, two-formulation, multiple-dose, parallel-design study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-23', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-23', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax,ss,', 'timeFrame': 'Up to Day456', 'description': 'Maximum plasma concentration at steady state'}, {'measure': 'AUCτ,ss', 'timeFrame': 'Up to Day456', 'description': 'Area under the plasma concentration-time curve over a dosing interval at steady state'}], 'secondaryOutcomes': [{'measure': 'Title:Incidence and severity of adverse events (AEs)', 'timeFrame': 'Up to Day456', 'description': 'The frequency and degree of harmfulness of adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'A randomized, open-label, multi-center, two-drug, multiple-dose, parallel-design study was conducted among patients with schizophrenia in China to evaluate the bioequivalence of the test formulation paliperidone palmitate (3M) produced by CSPC zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. and the reference formulation paliperidone palmitate injection (3M) (trade name: Santodar) of Janssen Pharmaceutica N.V.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/m\\^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.'}, 'identificationModule': {'nctId': 'NCT07493551', 'briefTitle': 'A Bioequivalence Study of PP3M in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Multicenter, Two-formulation, Multiple-dose, Parallel-design Bioequivalence Study of Paliperidone Palmitate Injection (3M) in Chinese Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'SYHF2037-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Test product', 'description': 'Paliperidone Palmitate Injection (3M), 1.75 mL: 350 mg', 'interventionNames': ['Drug: Paliperidone Palmitate Injection (3M)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference product', 'description': 'Invega Trinza, 1.75 mL: 350 mg', 'interventionNames': ['Drug: Paliperidone Palmitate Injection (3M)']}], 'interventions': [{'name': 'Paliperidone Palmitate Injection (3M)', 'type': 'DRUG', 'otherNames': ['SYHF2037'], 'description': 'Intramuscular injection', 'armGroupLabels': ['Reference product', 'Test product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100120', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gang Wang, M.D.', 'role': 'CONTACT', 'email': 'adyyjg@163.com', 'phone': '010-58303236'}, {'name': 'Gang Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anning Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anding Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Clinical Trials Information Group officer', 'role': 'CONTACT', 'email': 'ctr-contact@cspc.cn', 'phone': '86-0311-69085587'}], 'overallOfficials': [{'name': 'Gang Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anding Hospital Capital Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}