A Bioequivalence Study of PP3M in Patients With Schizophr... | NCT07493551

Studies
A Bioequivalence Study of PP3M in Patients With Schizophrenia

NCT07493551

Sponsor

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Status

Recruiting

Last Update Posted

Mar 25, 2026Actual

Enrollment

260Estimated

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate Injection (3M)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 9, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 4, 2026

First Submission Date that Met QC Criteria

Mar 23, 2026

First Posted Date

Mar 25, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2026

Last Update Posted Date

Mar 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test product	Active Comparator	Paliperidone Palmitate Injection (3M), 1.75 mL: 350 mg	Drug: Paliperidone Palmitate Injection (3M)
Reference product	Active Comparator	Invega Trinza, 1.75 mL: 350 mg	Drug: Paliperidone Palmitate Injection (3M)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paliperidone Palmitate Injection (3M)	Drug	Intramuscular injection	Reference product Test product

Outcomes Module

Primary Outcomes

Measure	Description	Time 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 Outcomes

Measure	Description	Time Frame
Title:Incidence and severity of adverse events (AEs)	The frequency and degree of harmfulness of adverse events	Up to Day456

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Information Group officer	Contact	86-0311-69085587		ctr-contact@cspc.cn

Overall Officials

Name	Affiliation	Role
Gang Wang, M.D.	Beijing Anding Hospital Capital Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anding Hospital Capital Medical University	Recruiting	Beijing	Beijing Municipality	100120	China

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068882	Paliperidone Palmitate

Ancestor Terms

ID	Term
D007555	Isoxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided