Actively Recruiting
A Bioequivalence Study of PP3M in Patients With Schizophrenia
Led by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Updated on 2026-03-25
260
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Bioequivalence Study of PP3M in Patients With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 65 years old (including 18 and 65 years old)
- Diagnosed with schizophrenia by ICD-10 criteria before screening
- Male patients weighing at least 50.0 kg, female patients weighing at least 45.0 kg
- Body mass index between 19.0 and 35.0 kg/m2 (including 19.0 and 35.0)
- Positive and Negative Syndrome Scale (PANSS) total score below 70 at screening and baseline
- Clinical Global Impression-Severity (CGI-S) score below 4 at screening and baseline
- Patients and their guardians voluntarily sign informed consent and can comply with study requirements
You will not qualify if you...
- Allergic or have a clear history of allergies to the trial drugs or their components
- Cardiovascular, liver, kidney, gastrointestinal, psychiatric, or neurological diseases that may affect trial participation, as determined by the investigator
- History of tardive dyskinesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100120
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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