Comparing a new 3‑month paliperidone palmitate injection with Invega Trinza for people 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

This study will test whether a 3‑month paliperidone palmitate injection made by CSPC works the same as Invega Trinza for adults with schizophrenia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07493551 on ClinicalTrials.gov

What this trial studies

This is a randomized, open‑label, multiple‑dose, parallel trial conducted in China comparing a test paliperidone palmitate 3‑month formulation to the marketed 3‑month reference product. Adult patients with stable schizophrenia who meet weight, BMI, and symptom severity limits were enrolled and randomized to receive one of the two formulations. The main goal is to demonstrate bioequivalence between the test and reference products using repeated dosing and pharmacokinetic measurements, with safety and tolerability monitored throughout. The trial was conducted at participating centers including Beijing Anding Hospital.

Who should consider this trial

Good fit: Adults aged 18–65 with a diagnosis of schizophrenia who meet the study's weight and BMI requirements, have relatively stable symptoms (PANSS <70 and CGI‑S <4), can consent with their guardian if needed, and have no allergy to the drug are ideal candidates.

Not a fit: People with recent significant cardiovascular, liver, kidney, gastrointestinal, psychiatric, or neurological conditions, a history of tardive dyskinesia, known allergy to paliperidone palmitate, or who do not meet the weight/BMI or symptom criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If the formulations are bioequivalent, patients could have an alternative 3‑month injectable option that may increase supply options and potentially reduce cost or improve access.

How similar studies have performed: Paliperidone palmitate 3‑month (Invega Trinza) is an approved, established treatment and bioequivalence studies comparing generic or alternative formulations to the reference product are common and have been successfully conducted for similar long‑acting injectables.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anding Hospital Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Gang Wang, M.D. — Beijing Anding Hospital Capital Medical University
• Study coordinator: Clinical Trials Information Group officer

Conditions Schizophrenia