A Bioequivalence Study of PP3M in Patients With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paliperidone Palmitate Injection (3M).
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Open-label, Multicenter, Two-formulation, Multiple-dose, Parallel-design Bioequivalence Study of Paliperidone Palmitate Injection (3M) in Chinese Patients With Schizophrenia
Overview
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.
Detailed description
A randomized, open-label, multi-center, two-drug, multiple-dose, parallel-design study was conducted among patients with schizophrenia in China to evaluate the bioequivalence of the test formulation paliperidone palmitate (3M) produced by CSPC zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. and the reference formulation paliperidone palmitate injection (3M) (trade name: Santodar) of Janssen Pharmaceutica N.V.
Interventions
- Drug Paliperidone Palmitate Injection (3M)
Intramuscular injection
Primary outcome measures
- Cmax,ss, [Time frame: Up to Day456]
- AUCτ,ss [Time frame: Up to Day456]
Secondary outcome measures (1)
- Title:Incidence and severity of adverse events (AEs) [Time frame: Up to Day456]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Anding Hospital Capital Medical University — Beijing
Identifiers
NCT: NCT07493551 · SYHF2037-001