SchizophreniaNCT07493551
A Bioequivalence Study of PP3M in Patients With Schizophrenia
A study testing Paliperidone Palmitate Injection (3M) in people with Schizophrenia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
Trial 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. 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 (3M)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, 100120
Gang Wang, M.D., 010-58303236, adyyjg@163.com
Gang Wang, M.D.
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone Palmitate Injection (3M)
- 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 (3M)Drug
Also called SYHF2037
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Test product | Active comparator | Paliperidone Palmitate Injection (3M), 1.75 mL: 350 mg Receives: Drug: Paliperidone Palmitate Injection (3M) |
| Reference product | Active comparator | Invega Trinza, 1.75 mL: 350 mg Receives: Drug: Paliperidone Palmitate Injection (3M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss,
Maximum plasma concentration at steady state
Measured: Up to Day456
AUCτ,ss
Area under the plasma concentration-time curve over a dosing interval at steady state
Measured: Up to Day456
Secondary outcomes (1)
Title:Incidence and severity of adverse events (AEs)
The frequency and degree of harmfulness of adverse events
Measured: Up to Day456
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start9 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Model description
- Open-label, multicenter, two-formulation, multiple-dose, parallel-design study
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gang Wang, M.D., Principal investigator, Beijing Anding Hospital Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493551
- Sponsor's protocol ID
- SYHF2037-001
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 25 Mar 2026
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07493551
- Acronym / sponsor ID
- SYHF2037-001
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Mar 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, multicenter, two-formulation, multiple-dose, parallel-design study
| Arm | Type | Receives |
|---|---|---|
| Test product | Active comparator | Drug: Paliperidone Palmitate Injection (3M)Paliperidone Palmitate Injection (3M), 1.75 mL: 350 mg |
| Reference product | Active comparator | Drug: Paliperidone Palmitate Injection (3M)Invega Trinza, 1.75 mL: 350 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 (3M)Also: SYHF2037Intramuscular injection | Drug | Reference product, Test product |
Primary outcome
Cmax,ss,
Time frame: Up to Day456
Maximum plasma concentration at steady state
AUCτ,ss
Time frame: Up to Day456
Area under the plasma concentration-time curve over a dosing interval at steady state
1 secondary outcome
Title:Incidence and severity of adverse events (AEs)
Time frame: Up to Day456
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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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.
Gang Wang, M.D. principal investigator
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 (3M) 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax,ss, (time frame: Up to Day456). 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 25 Mar 2026.