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.

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.

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.