SchizophreniaNCT07268430
Bioequivalence Study of Long-Acting Paliperidone Palmitate in Patients With Schizophrenia
A study testing Paliperidone Palmitate Injection(PP1M) and Paliperidone Palmitate Injection(PP1M)(Reference Group) in people with Schizophrenia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
Trial summary
This multicenter, randomized, open-label, parallel-group, multiple-dose study is designed to evaluate the bioequivalence, at pharmacokinetic steady state, of a paliperidone palmitate injection manufactured by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone Palmitate Injection(PP1M) and Paliperidone Palmitate Injection(PP1M)(Reference Group)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2023to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years inclusive at the time of consent.
- Diagnosis of schizophrenia (ICD-10 criteria) prior to screening.
- PANSS total score ≤70 at screening and at baseline.
- CGI-S score ≤4 at screening and at baseline.
- Body weight at screening: ≥50.0 kg (male) or ≥45.0 kg (female); body mass index (BMI) 19.0 to 35.0 kg/m2 (inclusive).
- The participant and/or partner have no plans for pregnancy during the study and for 6 months after the last dose, and agree to use effective contraception (oral contraceptives are not allowed).
- Signed informed consent and willingness and ability to comply with all study requirements.
Who cannot join
- Known or suspected hypersensitivity to the study drug (paliperidone palmitate) or any of its components.
- Diagnosis per ICD-10 or DSM-5 of any psychiatric disorder other than schizophrenia.
- Clinically significant diseases or abnormalities, as judged by the investigator, in the respiratory, cardiovascular, gastrointestinal, genitourinary, reproductive, nervous, endocrine, or immune systems that may affect participant safety or interfere with study participation.
- Laboratory abnormalities at screening or baseline meeting any of the following: (1) total bilirubin >1.5 × ULN, or AST or ALT >2 × ULN; (2) creatinine clearance (CLcr) <90 mL/min; (3) white blood cell count <3 × 10^9/L, or absolute neutrophil count <1.5 × 10^9/L, or platelets <80 × 10^9/L.
- History of orthostatic hypotension or syncope due to orthostatic hypotension (except if stable for >6 months); or at screening/baseline, a decrease in systolic blood pressure ≥20 mmHg or diastolic blood pressure ≥10 mmHg within 3 minutes after changing from supine to standing.
- Congenital long QT syndrome; uncontrolled or significant cardiovascular disease, including congestive heart failure of NYHA class II or higher, unstable angina, or myocardial infarction within 6 months prior to first study dose; significant arrhythmias (including frequent premature ventricular contractions), or clinically significant arrhythmias requiring treatment at screening; QTc >450 ms (male) or >460 ms (female) at screening or baseline; risk factors for torsades de pointes or sudden death (e.g., bradycardia, clinically significant hypokalemia or hypomagnesemia, current use of medications that prolong QTc); or other clinically significant ECG abnormalities as judged by the investigator.
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- Past or current neuroleptic malignant syndrome.
- Parkinson's disease, Lewy body dementia, or dementia-related psychosis.
- Past or current seizure or convulsive disorders (except childhood febrile seizures), or stroke or transient ischemic attack within 1 year prior to consent.
- History of tardive dyskinesia induced by risperidone, paliperidone, or other antipsychotics.
- Uncontrolled diabetes mellitus, or HbA1c ≥7% at screening or baseline.
- Electroconvulsive therapy within 28 days prior to consent.
- Blood loss ≥400 mL within 3 months prior to consent, or ≥200 mL within 1 month prior to consent due to donation, surgery, or other causes.
- Esophageal motility disorders, dysphagia, or other conditions that confer risk of aspiration pneumonia.
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or treponemal (syphilis) antibody.
- Harmful alcohol use: >14 units per week (1 unit = 360 mL beer, or 150 mL wine, or 45 mL spirits).
- Use of any investigational drug within 1 month prior to first study dose (excluding paliperidone palmitate or placebo), or prior participation in a gene therapy or cell therapy clinical trial such that, in the investigator's judgment, the participant is not suitable for this study.
- Major surgery within 3 months prior to consent, or planned surgery within 1 month after study completion.
- High suicide risk: C-SSRS suicidal ideation items 4 or 5 answered "Yes" within the past 6 months at screening/baseline; or suicidal behavior within the past 6 months; or, in the investigator's judgment, a serious risk of suicide.
- Prohibited medications/treatments: (1) ziprasidone or thioridazine within 4 weeks prior to consent; (2) any other long-acting injectable antipsychotic received within one labeled dosing interval prior to consent (except risperidone microspheres), or receipt of risperidone microspheres (e.g., Hengde®) within 6 weeks prior to consent; (3) non-selective or irreversible monoamine oxidase inhibitors within 1 month prior to first dose; (4) strong or moderate inhibitors or inducers of CYP3A4, CYP2D6, or P-gp within 2 weeks prior to consent.
- Pregnant, breastfeeding, or planning pregnancy; except for women who are postmenopausal for ≥1 year or surgically sterile (e.g., bilateral tubal ligation with non-recanalized tubes, bilateral oophorectomy, or hysterectomy).
- Drug abuse history, illicit drug use, or positive drug abuse screening within 1 year prior to consent.
- Clinically significant history of syncope related to needles or blood draws. Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: A Multicenter, Randomized, Open-Label, Parallel-Group, Multiple-Dose Bioequivalence Study of Paliperidone Palmitate Injection in Chinese Patients With Schizophrenia
This multicenter, randomized, open-label, parallel-group, multiple-dose study is designed to evaluate the bioequivalence, at pharmacokinetic steady state, of a paliperidone palmitate injection manufactured by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (Test Group) and a paliperidone palmitate injection manufactured by Janssen Pharmaceutica N.V. (Reference Group) in patients with schizophrenia in China. Bioequivalence will be assessed based on steady-state pharmacokinetic parameters after repeated intramuscular administration (e.g., Cmax,ss and AUCτ). The safety and tolerability of the test and reference products will also be evaluated.
Read the detailed description
Purpose: This trial was conducted to evaluate the bioequivalence of a test (T) and a reference (R) formulation of once-monthly paliperidone palmitate (PP1M) in patients with schizophrenia.
Patients and methods: In this randomized, open-label, parallel-group, steady-state bioequivalence study, patients with stabilized schizophrenia were randomized 1:1 to receive T or R formulation. The regimen was 150 mg deltoid on Day 1, then 100 mg deltoid on Day 8, followed by five subsequent 100 mg gluteal injections every 28 days. The primary objective was to demonstrate steady-state bioequivalence. The primary endpoints were key pharmacokinetic parameters of paliperidone, including steady-state maximum concentration (Cmax,ss) and the area under the concentration-time curve over a dosing interval at steady state (AUCτ,ss). Bioequivalence was shown if the 90% confidence interval (CI) for the ratio of the geometric least squares means of the pharmacokinetic parameters (AUCτ,ss and Cmax,ss) fell within 80%-125%.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone Palmitate Injection(PP1M), Paliperidone Palmitate Injection(PP1M)(Reference Group)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone Palmitate Injection(PP1M)Drug
Also called SYHF2036
Paliperidone palmitate injection will be administered intramuscularly according to two dosing regimens based on participants' prior exposure to paliperidone palmitate:
- Participants with no prior use of paliperidone palmitate injection, or whose last dose was administered more than 6 months ago (for the once-monthly formulation), or more than 5 half-lives ago (for the once-every-3-months formulation): Day 1: 150 mg, deltoid muscle Day 8: 100 mg, deltoid muscle Followed by 100 mg every 28 days thereafter Approximate treatment duration: 148 days
- Participants who have previously received at least 3 injections (including 150 mg Day 1 loading dose and 100 mg Day 8 loading dose, deltoid muscle) of the once-monthly formulation (100 mg) of paliperidone palmitate and whose last dose was given within 4 to 6 weeks prior to enrollment:
Continue with 100 mg every 28 days Approximate treatment duration: 113 days
Paliperidone Palmitate Injection(PP1M)(Reference Group)Drug
Also called Invega Sustenna
Paliperidone palmitate injection will be administered intramuscularly according to two dosing regimens based on participants' prior exposure to paliperidone palmitate:
- Participants with no prior use of paliperidone palmitate injection, or whose last dose was administered more than 6 months ago (for the once-monthly formulation), or more than 5 half-lives ago (for the once-every-3-months formulation): Day 1: 150 mg, deltoid muscle Day 8: 100 mg, deltoid muscle Followed by 100 mg every 28 days thereafter Approximate treatment duration: 148 days
- Participants who have previously received at least 3 injections (including 150 mg Day 1 loading dose and 100 mg Day 8 loading dose, deltoid muscle) of the once-monthly formulation (100 mg) of paliperidone palmitate and whose last dose was given within 4 to 6 weeks prior to enrollment:
Continue with 100 mg every 28 days Approximate treatment duration: 113 days
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone Palmitate 1-Month Formulation (PP1M) (Test Group) | Experimental | Participants will receive paliperidone palmitate injection manufactured by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., administered intramuscularly. Dosing regimen: 150 mg on Day 1 and 100 mg on Day 8, followed by 100 mg every 28 days (starting Day 1 regimen); or 100 mg every 28 days (starting Day 36 regimen). Receives: Drug: Paliperidone Palmitate Injection(PP1M); Drug: Paliperidone Palmitate Injection(PP1M)(Reference Group) |
| Paliperidone Palmitate 1-Month Formulation (PP1M) (Reference Group) | Active comparator | Participants will receive paliperidone palmitate injection (Invega Sustenna®) manufactured by Janssen Pharmaceutica N.V., administered intramuscularly. Dosing regimen: 150 mg on Day 1 and 100 mg on Day 8, followed by 100 mg every 28 days (starting Day 1 regimen); or 100 mg every 28 days (starting Day 36 regimen). Receives: Drug: Paliperidone Palmitate Injection(PP1M); Drug: Paliperidone Palmitate Injection(PP1M)(Reference Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Title:Steady-State Peak Concentration (Cmax,ss) of Paliperidone After Intramuscular Administration.
Steady-state maximum plasma concentration (Cmax,ss) will be determined to assess bioequivalence between the test and reference formulations of paliperidone palmitate injection after multiple intramuscular doses in patients with schizophrenia.
Measured: Day148~Day176
Area Under the Concentration-Time Curve over Dosing Interval (AUCτ,ss) of Paliperidone After Intramuscular Administration.
Area under the plasma concentration-time curve during the dosing interval (AUCτ,ss) will be determined to assess bioequivalence between the test and reference formulations of paliperidone palmitate injection after multiple intramuscular doses in patients with schizophrenia.
Measured: Day148~Day176
Secondary outcomes (12)
Steady-State Trough Concentration (Ctau,ss)
Steady-state plasma trough concentration (Ctau,ss) of paliperidone will be measured to further characterize pharmacokinetics and assess bioequivalence between test and reference group.
Measured: Day1~Day176
Steady-State Average Concentration (Cav,ss)
Average plasma concentration during the dosing interval (Cav,ss) will be evaluated at steady state.
Measured: Day1~Day176
Steady-State Minimum Concentration (Cmin,ss)
Minimum plasma concentration during the dosing interval (Cmin,ss) at steady state will be determined.
Measured: Day1~Day176
Time to Maximum Concentration at Steady State (Tmax,ss)
The time to reach maximum plasma concentration (Tmax,ss) will be assessed at steady state.
Measured: Day1~Day176
Degree of Fluctuation (DF) and Swing at Steady State
The degree of fluctuation (DF) and swing of paliperidone plasma concentrations will be calculated at steady state.
Measured: Day1~Day176
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number and percentage of participants experiencing ≥1 treatment-emergent adverse event (TEAE) after first dose; events coded by MedDRA (System Organ Class and Preferred Term); severity (mild/moderate/severe) and relationship to study drug assessed by investigator.
Measured: Day1~Day176
Number of Participants With Serious Adverse Events (SAEs)
Number and percentage of participants experiencing ≥1 SAE, defined per ICH-GCP criteria; events coded by MedDRA (SOC/PT).
Measured: Day1~Day176
Clinical Global Impression-Severity (CGI-S)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Mean (SD) change in CGI-S score from baseline to end of treatment. Clinical Global Impression - Severity (CGI-S): The Clinical Global Impression - Severity Scale ranges from 1 to 7 (1 = normal, not at all ill; 7 = among the most extremely ill), and higher scores indicate worse clinical severity (worse outcome).
Measured: Day1~Day176
Proportion of Participants With Suicidal Ideation or Behavior (C-SSRS)
Number and percentage of participants with suicidal ideation (items 4 or 5) and/or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS).
Columbia-Suicide Severity Rating Scale (C-SSRS): The Columbia-Suicide Severity Rating Scale rates suicidal ideation severity from 1 to 5 (0 = no suicidal ideation; 5 = most severe ideation), while suicidal behavior is recorded as present/absent; higher ideation category indicates a worse outcome (greater suicide risk).
Measured: Day1~Day176
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score
Mean (SD) change in BARS global score from baseline to end of treatment. Barnes Akathisia Rating Scale (BARS): The Barnes Akathisia Rating Scale global score ranges from 0 to 5 (0 = no akathisia; 5 = severe akathisia), and higher scores indicate more severe akathisia (worse outcome).
Measured: Day1~Day176
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
Mean (SD) change in AIMS total score from baseline to end of treatment. Abnormal Involuntary Movement Scale (AIMS): The Abnormal Involuntary Movement Scale total score commonly uses the sum of items 1-7 and ranges from 0 to 28 (0 = no abnormal movements; 28 = maximum severity on rated items); higher scores indicate more severe abnormal involuntary movements (worse outcome).
Measured: Day1~Day176
Change From Baseline in Simpson-Angus Scale (SAS) Total Score
Mean (SD) change in SAS total score from baseline to end of treatment. Simpson-Angus Scale (SAS): The Simpson-Angus Scale total score ranges from 0 to 40 (10 items each scored 0-4), and higher scores indicate more severe drug-induced parkinsonism (worse outcome).
Measured: Day1~Day176
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start18 Dec 2023
- Primary completion25 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gang Wang, M.D., Study chair, Beijing Anding Hospital Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268430
- Sponsor's protocol ID
- SYHF2036-001
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Parallel-Group, Multiple-Dose Bioequivalence Study of Paliperidone Palmitate Injection in Chinese Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07268430
- Acronym / sponsor ID
- SYHF2036-001
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, open-label, parallel-group, multiple-dose study is designed to evaluate the bioequivalence, at pharmacokinetic steady state, of a paliperidone palmitate injection manufactured by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (Test Group) and a paliperidone palmitate injection manufactured by Janssen Pharmaceutica N.V. (Reference Group) in patients with schizophrenia in China. Bioequivalence will be assessed based on steady-state pharmacokinetic parameters after repeated intramuscular administration (e.g., Cmax,ss and AUCτ). The safety and tolerability of the test and reference products will also be evaluated.
Detailed description
Purpose: This trial was conducted to evaluate the bioequivalence of a test (T) and a reference (R) formulation of once-monthly paliperidone palmitate (PP1M) in patients with schizophrenia.
Patients and methods: In this randomized, open-label, parallel-group, steady-state bioequivalence study, patients with stabilized schizophrenia were randomized 1:1 to receive T or R formulation. The regimen was 150 mg deltoid on Day 1, then 100 mg deltoid on Day 8, followed by five subsequent 100 mg gluteal injections every 28 days. The primary objective was to demonstrate steady-state bioequivalence. The primary endpoints were key pharmacokinetic parameters of paliperidone, including steady-state maximum concentration (Cmax,ss) and the area under the concentration-time curve over a dosing interval at steady state (AUCτ,ss). Bioequivalence was shown if the 90% confidence interval (CI) for the ratio of the geometric least squares means of the pharmacokinetic parameters (AUCτ,ss and Cmax,ss) fell within 80%-125%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paliperidone Palmitate 1-Month Formulation (PP1M) (Test Group) | Experimental | Drug: Paliperidone Palmitate Injection(PP1M), Drug: Paliperidone Palmitate Injection(PP1M)(Reference Group)Participants will receive paliperidone palmitate injection manufactured by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., administered intramuscularly. Dosing regimen: 150 mg on Day 1 and 100 mg on Day 8, followed by 100 mg every 28 days (starting Day 1 regimen); or 100 mg every 28 days (starting Day 36 regimen). |
| Paliperidone Palmitate 1-Month Formulation (PP1M) (Reference Group) | Active comparator | Drug: Paliperidone Palmitate Injection(PP1M), Drug: Paliperidone Palmitate Injection(PP1M)(Reference Group)Participants will receive paliperidone palmitate injection (Invega Sustenna®) manufactured by Janssen Pharmaceutica N.V., administered intramuscularly. Dosing regimen: 150 mg on Day 1 and 100 mg on Day 8, followed by 100 mg every 28 days (starting Day 1 regimen); or 100 mg every 28 days (starting Day 36 regimen). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 65 years inclusive at the time of consent.
- Diagnosis of schizophrenia (ICD-10 criteria) prior to screening.
- PANSS total score ≤70 at screening and at baseline.
- CGI-S score ≤4 at screening and at baseline.
- Body weight at screening: ≥50.0 kg (male) or ≥45.0 kg (female); body mass index (BMI) 19.0 to 35.0 kg/m2 (inclusive).
Key exclusion criteria (23 listed)
- Known or suspected hypersensitivity to the study drug (paliperidone palmitate) or any of its components.
- Diagnosis per ICD-10 or DSM-5 of any psychiatric disorder other than schizophrenia.
- Clinically significant diseases or abnormalities, as judged by the investigator, in the respiratory, cardiovascular, gastrointestinal, genitourinary, reproductive, nervous, endocrine, or immune systems that may affect participant safety or interfere with study participation.
- Laboratory abnormalities at screening or baseline meeting any of the following: (1) total bilirubin >1.5 × ULN, or AST or ALT >2 × ULN; (2) creatinine clearance (CLcr) <90 mL/min; (3) white blood cell count <3 × 10^9/L, or absolute neutrophil count <1.5 × 10^9/L, or platelets <80 × 10^9/L.
- History of orthostatic hypotension or syncope due to orthostatic hypotension (except if stable for >6 months); or at screening/baseline, a decrease in systolic blood pressure ≥20 mmHg or diastolic blood pressure ≥10 mmHg within 3 minutes after changing from supine to standing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paliperidone Palmitate Injection(PP1M)Also: SYHF2036Paliperidone palmitate injection will be administered intramuscularly according to two dosing regimens based on participants' prior exposure to paliperidone palmitate: 1. Participants with no prior use of paliperidone palmitate injection, or whose last dose was administered more than 6 months ago (for the once-monthly formulation), or more than 5 half-lives ago (for the once-every-3-months formulation): Day 1: 150 mg, deltoid muscle Day 8: 100 mg, deltoid muscle Followed by 100 mg every 28 days thereafter Approximate treatment duration: 148 days 2. Participants who have previously received at least 3 injections (including 150 mg Day 1 loading dose and 100 mg Day 8 loading dose, deltoid muscle) of the once-monthly formulation (100 mg) of paliperidone palmitate and whose last dose was given within 4 to 6 weeks prior to enrollment: Continue with 100 mg every 28 days Approximate treatment duration: 113 days | Drug | Paliperidone Palmitate 1-Month Formulation (PP1M) (Reference Group), Paliperidone Palmitate 1-Month Formulation (PP1M) (Test Group) |
| Paliperidone Palmitate Injection(PP1M)(Reference Group)Also: Invega SustennaPaliperidone palmitate injection will be administered intramuscularly according to two dosing regimens based on participants' prior exposure to paliperidone palmitate: 1. Participants with no prior use of paliperidone palmitate injection, or whose last dose was administered more than 6 months ago (for the once-monthly formulation), or more than 5 half-lives ago (for the once-every-3-months formulation): Day 1: 150 mg, deltoid muscle Day 8: 100 mg, deltoid muscle Followed by 100 mg every 28 days thereafter Approximate treatment duration: 148 days 2. Participants who have previously received at least 3 injections (including 150 mg Day 1 loading dose and 100 mg Day 8 loading dose, deltoid muscle) of the once-monthly formulation (100 mg) of paliperidone palmitate and whose last dose was given within 4 to 6 weeks prior to enrollment: Continue with 100 mg every 28 days Approximate treatment duration: 113 days | Drug | Paliperidone Palmitate 1-Month Formulation (PP1M) (Reference Group), Paliperidone Palmitate 1-Month Formulation (PP1M) (Test Group) |
Primary outcome
Title:Steady-State Peak Concentration (Cmax,ss) of Paliperidone After Intramuscular Administration.
Time frame: Day148~Day176
Steady-state maximum plasma concentration (Cmax,ss) will be determined to assess bioequivalence between the test and reference formulations of paliperidone palmitate injection after multiple intramuscular doses in patients with schizophrenia.
Area Under the Concentration-Time Curve over Dosing Interval (AUCτ,ss) of Paliperidone After Intramuscular Administration.
Time frame: Day148~Day176
Area under the plasma concentration-time curve during the dosing interval (AUCτ,ss) will be determined to assess bioequivalence between the test and reference formulations of paliperidone palmitate injection after multiple intramuscular doses in patients with schizophrenia.
12 secondary outcomes
Steady-State Trough Concentration (Ctau,ss)
Time frame: Day1~Day176
Steady-State Average Concentration (Cav,ss)
Time frame: Day1~Day176
Steady-State Minimum Concentration (Cmin,ss)
Time frame: Day1~Day176
Time to Maximum Concentration at Steady State (Tmax,ss)
Time frame: Day1~Day176
Degree of Fluctuation (DF) and Swing at Steady State
Time frame: Day1~Day176
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day1~Day176
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Day1~Day176
Clinical Global Impression-Severity (CGI-S)
Time frame: Day1~Day176
Proportion of Participants With Suicidal Ideation or Behavior (C-SSRS)
Time frame: Day1~Day176
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score
Time frame: Day1~Day176
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
Time frame: Day1~Day176
Change From Baseline in Simpson-Angus Scale (SAS) Total Score
Time frame: Day1~Day176
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Wang, M.D. study chair
Beijing Anding Hospital Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paliperidone Palmitate Injection(PP1M) and Paliperidone Palmitate Injection(PP1M)(Reference Group) in people with Schizophrenia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Title:Steady-State Peak Concentration (Cmax,ss) of Paliperidone After Intramuscular Administration. (time frame: Day148~Day176). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.