NCT07493551Recruiting
A Bioequivalence Study of PP3M in Patients 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
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- 9 Oct 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Diseases
- Schizophrenia
- NCT number
- NCT07493551
What you commit to
- Study type: Interventional
- Planned participants: 260
- From 9 Oct 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anding Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.