beta
Trial Radar AI
Clinical Trial NCT07493551 for Schizophrenia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

A Bioequivalence Study of PP3M in Patients With Schizophrenia 260

Recruiting
Clinical Trial NCT07493551 is an interventional study for Schizophrenia that is recruiting. It started on 9 October 2024 with plans to enroll 260 participants. Led by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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.
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.
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

Conditions
Schizophrenia
Other Study IDs
  • SYHF2037-001
NCT ID Number
NCT07493551
Start Date (Actual)
2024-10-09
Last Update Posted
2026-03-25
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
260
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorTest product
Paliperidone Palmitate Injection (3M), 1.75 mL: 350 mg
Paliperidone Palmitate Injection (3M)
Intramuscular injection
Active ComparatorReference product
Invega Trinza, 1.75 mL: 350 mg
Paliperidone Palmitate Injection (3M)
Intramuscular injection
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Cmax,ss,
Maximum plasma concentration at steady state
Up to Day456
AUCτ,ss
Area under the plasma concentration-time curve over a dosing interval at steady state
Up to Day456
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Title:Incidence and severity of adverse events (AEs)
The frequency and degree of harmfulness of adverse events
Up to Day456
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. logoCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Study Central Contact
Contact: Clinical Trials Information Group officer, 86-0311-69085587, [email protected]
1 Study Locations in 1 Countries

Beijing Municipality

Beijing Anding Hospital Capital Medical University, Beijing, Beijing Municipality, 100120, China
Gang Wang, M.D., Contact, 010-58303236, [email protected]
Gang Wang, M.D., Principal Investigator
Anning Li, M.D., Principal Investigator
Recruiting