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NCT Number: NCT07493551

A Bioequivalence Study of PP3M in 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, 100120, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paliperidone Palmitate Injection (3M)

Drug

Intramuscular injection

Other names: SYHF2037

Primary outcomes

  1. Cmax,ss,

    Time frame: Up to Day456

    Maximum plasma concentration at steady state

  2. AUCτ,ss

    Time frame: Up to Day456

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

Secondary outcomes

  1. Title:Incidence and severity of adverse events (AEs)

    Time frame: Up to Day456

    The frequency and degree of harmfulness of adverse events

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Sponsors and collaborators

Lead sponsor

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Multicenter, Two-formulation, Multiple-dose, Parallel-design Bioequivalence Study of Paliperidone Palmitate Injection (3M) in Chinese Patients With Schizophrenia

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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