Actively Recruiting
A Randomized, Open-label, Multicenter, Two-formulation, Multiple-dose, Parallel-design Bioequivalence Study of Paliperidone Palmitate Injection (3M) in Chinese Patients With Schizophrenia
Led by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Updated on 2026-03-25
260
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
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 (AUCτ,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.
CONDITIONS
Brief Title
A Bioequivalence Study of PP3M in Patients With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 65 years old (including 18 and 65 years old)
- Diagnosed with schizophrenia according to ICD-10 criteria before screening
- Male patients with weight at least 50.0 kg, female patients with weight at least 45.0 kg
- Body mass index (BMI) between 19.0 and 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) score lower than 4 at screening and baseline
- Patients and their guardians voluntarily sign informed consent and can comply with study requirements
You will not qualify if you...
- Allergy or clear history of allergies to trial drugs or their components
- Cardiovascular, liver, kidney, gastrointestinal, psychiatric, or neurological diseases that may affect trial participation as judged by the investigator
- History of tardive dyskinesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 456 days
Participants receive paliperidone palmitate injections (3M) as part of the study to evaluate bioequivalence between two formulations.
Multiple visits for drug administration and monitoring
Trial Site Locations
Total: 1 location
1
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100120
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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