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New treatment option for Schizophrenia
Official title A Bioequivalence Study of PP3M in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT07493551
What this study is testing
What is Paliperidone Palmitate Injection (3M)?
Paliperidone Palmitate Injection (3M) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for schizophrenia.
Also referred to as SYHF2037.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- History of tardive dyskinesia.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.