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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ctr-contact@cspc.cn
• Phone: 86-0311-69085587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.