A Bioequivalence Study of PP3M in Patients With Schizophrenia

NCT07493551 | Recruiting

• 1 other identifier: SYHF2037-001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Cmax,ss,

  Maximum plasma concentration at steady state

  Up to Day456

• AUCτ,ss

  Area under the plasma concentration-time curve over a dosing interval at steady state

  Up to Day456

Secondary Outcomes (1)

• Title:Incidence and severity of adverse events (AEs)

  Up to Day456

Study Arms (2)

Test product

ACTIVE COMPARATOR

Paliperidone Palmitate Injection (3M), 1.75 mL: 350 mg

Drug: Paliperidone Palmitate Injection (3M)

Reference product

ACTIVE COMPARATOR

Invega Trinza, 1.75 mL: 350 mg

Drug: Paliperidone Palmitate Injection (3M)

Interventions

Paliperidone Palmitate Injection (3M) DRUG

Intramuscular injection

Also known as: SYHF2037

Reference product; Test product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old (including 18 and 65 years old).
• Patients diagnosed with schizophrenia (by ICD-10 criteria) before screening.
• 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).
• Positive and Negative Syndrome Scale (PANSS) total score lower than 70 at screening and baseline.
• Clinical Global Impression-Severity (CGI-S) lower than 4 at screening and baseline.
• Patients and their guardians voluntarily sign the ICF and are able to comply with the requirements of the study.

You may not qualify if:

• Be allergic, or have a clear history of allergies to trial drugs and components.
• Patients with cardiovascular, liver, kidney, gastrointestinal, psychiatric, or neurological diseases that may affect participation in the trial, as determined by the investigator.
• History of tardive dyskinesia.

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

Study Sites (1)

Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, 100120, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Gang Wang, M.D.

  Beijing Anding Hospital Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, multicenter, two-formulation, multiple-dose, parallel-design study

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 25, 2026
• Study Start: October 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)