NCT07493551 A Bioequivalence Study of PP3M in Patients With Schizophrenia
| NCT ID | NCT07493551 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2024-10-09 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2024-10-09 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Gang Wang, M.D.
PRINCIPAL INVESTIGATOR
Beijing Anding Hospital Capital Medical University
Frequently Asked Questions
Who can join the NCT07493551 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07493551 currently recruiting?
Yes, NCT07493551 is actively recruiting participants. Contact the research team at ctr-contact@cspc.cn for enrollment information.
Where is the NCT07493551 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07493551 clinical trial?
NCT07493551 is sponsored by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.. The principal investigator is Gang Wang, M.D. at Beijing Anding Hospital Capital Medical University. The trial plans to enroll 260 participants.
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