Comparing two paliperidone palmitate injections in Chinese adults with schizophrenia
Compares how a new and an existing injection behave in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: A Bioequivalence Study of PP3M in Patients With Schizophrenia
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07493551, who can take part
Where in China
- Beijing Anding Hospital, Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Trial code
- NCT07493551
- Record updated
- 25 March 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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.