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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Paliperidone Palmitate Injection (3M)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 86-0311-69085587; Email: ctr-contact@cspc.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100120
      • Recruiting
      • Beijing Anding Hospital Capital Medical University
      • Contact: Gang Wang, M.D.; Phone Number: 010-58303236; Email: adyyjg@163.com
      • Principal Investigator: Gang Wang, M.D.
      • Principal Investigator: Anning Li, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test product; Paliperidone Palmitate Injection (3M), 1.75 mL: 350 mg	Drug: Paliperidone Palmitate Injection (3M); Intramuscular injection; Other Names: SYHF2037
Active Comparator: Reference product; Invega Trinza, 1.75 mL: 350 mg	Drug: Paliperidone Palmitate Injection (3M); Intramuscular injection; Other Names: SYHF2037

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Title:Incidence and severity of adverse events (AEs)	The frequency and degree of harmfulness of adverse events	Up to Day456

Collaborators and Investigators

• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
• Investigators: Principal Investigator: Gang Wang, M.D., Beijing Anding Hospital Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Pyrimidines; Isoxazoles; Paliperidone Palmitate
• Other Study ID Numbers: SYHF2037-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No