Study Comparing Two Formulations of Paliperidone Palmitate Injection 3M in Chinese Adults with Schizophrenia Randomized, Open-label, Multicenter, Multiple-dose Bioequivalence Study

What this Trial Is About

Researchers are evaluating the bioequivalence of a test formulation of paliperidone palmitate injection 3M produced by CSPC Zhongnuo Pharmaceutical and the reference formulation Invega Trinza by Janssen Pharmaceutica in patients with schizophrenia. The study is randomized, open-label, and conducted in multiple centers in China to compare these two long-acting injectable drugs under multiple-dose administration. Participants will receive either the test drug or the reference drug, both given as intramuscular injections of 350 mg every three months. The study uses a parallel design with multiple doses to assess how similarly the two formulations behave in the body over time. During the study, patients will be monitored up to day 456 for maximum drug concentration Cmax,ss and total drug exposure AUC,ss. Safety is evaluated by tracking the incidence and severity of adverse events. Patients will visit the study centers regularly for assessments, and their adherence and clinical status will be closely observed throughout the trial.

A Bioequivalence Study of PP3M in Patients With Schizophrenia