SchizophreniaNCT07547384
Steady-state Bioequivalence Study of Aripiprazole for Injection in Patients With Schizophrenia.
A study testing Aripiprazole for Injection in people with Schizophrenia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..
Trial summary
The primary objective of this study is to evaluate the bioequivalence of aripiprazole for injection (Test product, 400 mg) compared with Abilify Maintena® (Reference product, 400 mg) at steady state in patients with schizophrenia.his is a multi-center, randomized, open-label, two-period, crossover study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2026to 5 Nov 2027
- Phase
- Interventional
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
- 1. Aged 18 to 65 years (inclusive), male or female.
- 2. Patients diagnosed with schizophrenia according to ICD-10 criteria, with a Positive and Negative Syndrome Scale (PANSS) total score ≤ 70, judged as clinically stable for at least 28 days prior to screening (no medication changes or hospitalization due to condition changes).
- 3. Receiving treatment with ≤ 2 other oral antipsychotic medications, which must have been at a stable dose for ≥ 14 days before the first study injection (excluding prohibited medications).
- 4. Body weight ≥ 45 kg for females and ≥ 50 kg for males; Body Mass Index (BMI) between 18.5 and 35.0 kg/m² (inclusive).
- 5. Subject or partner has no pregnancy plan and agrees to use effective non-drug contraception during the study and for six months after the last dose.
- 6. Subjects and their legal guardians voluntarily sign the Informed Consent Form (ICF) and are able to comply with all study requirements.
Who cannot join
- 1.Diagnosis of any psychiatric disorder other than schizophrenia according to ICD-10 criteria.
- 2.History or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, psychiatric, or neurological diseases that, in the investigator's judgment, would affect participation in the study.
- 3.Patients with Parkinson's disease, Lewy body dementia, or dementia-related psychosis.
- 4.History or presence of Neuroleptic Malignant Syndrome (NMS).
- 5.History or presence of epilepsy or convulsive disorders (except childhood febrile seizures), or a history of stroke or transient ischemic attack (TIA) within one year before signing the Informed Consent Form (ICF).
- 6.Concurrent tardive dyskinesia (or history) or severe akathisia.
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- 7.Esophageal motility dysfunction or dysphagia with a potential risk of aspiration pneumonia.
- 8.Cardiovascular Risks: Congenital long QT syndrome; presence of uncontrolled or significant cardiovascular disease, including NYHA Class II or higher heart failure, unstable angina, myocardial infarction, or significant arrhythmia/frequent ventricular premature beats within 6 months before the first dose; QTcF > 450 ms in males or > 470 ms in females; presence of risk factors for Torsades de Pointes or sudden death (such as bradycardia, clinically significant hypokalemia, or current use of QTc-prolonging medications; excluding bradycardia judged by the investigator to be risk-controllable and stable after treatment, corrected hypokalemia, or instances where QTc-prolonging medications are discontinued or evaluated as acceptable for stable use) or other clinically significant ECG abnormalities judged by the investigator as potentially affecting subject safety or interfering with study participation.
- 9.Blood Pressure Abnormalities: Poorly controlled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg after stable antihypertensive treatment); symptomatic hypotension; or orthostatic hypotension (SBP drop ≥ 20 mmHg or DBP drop ≥ 10 mmHg within 3 minutes of standing during screening or baseline).
- 10.Glycosylated hemoglobin (HbA1c) level ≥ 7% at screening or baseline.
- 11.Laboratory Abnormalities: 1) TBiL > 1.5 × ULN, or AST/ALT > 2 × ULN; 2) CLcr < 90 mL/min; 3) WBC < 3 × 10⁹/L, Neutrophils < 1.5 × 10⁹/L, Platelets < 75 × 10⁹/L, RBC < 3.0 × 10¹²/L, or Hemoglobin < 100 g/L.
- 12.Positive results for HBsAg, HCV-Ab, HIV-Ab, or Syphilis-Ab that, in the investigator's judgment, affect study participation.
- 13.Severe Suicide Risk: 1) Positive response to item 4 or 5 of "suicidal ideation" on C-SSRS within the past 6 months; 2) History of suicidal behavior within the past 6 months; or 3) Judged by the investigator to have a severe suicide risk.
- 14.Received electroconvulsive therapy (ECT) or invasive psychiatric treatment within 28 days before signing the ICF.
- 15.History of Blood Loss: Blood loss ≥ 400 mL within 3 months or ≥ 200 mL within 1 month before signing the ICF.
- 16.Major surgery within 3 months before signing the ICF, or planned surgery during the study or within one month after study completion.
- 17.Other Clinical Studies: Participation in any other drug clinical study within one month before the first dose (except for aripiprazole BE studies).
- 18.Long-acting Injectable (LAI) History: Prior treatment with non-aripiprazole LAIs where the interval since the last dose is shorter than the labeled dosing interval of that LAI; or a requirement for other LAIs during the study.
- 19.Medication Contraindications: Use of Chlorpromazine or Thioridazine within 28 days before the first dose; or use of strong/moderate CYP3A4 or CYP2D6 inhibitors or inducers within 14 days or five half-lives (whichever is longer).
- 20.Consumption of foods or beverages rich in xanthines, grapefruit, or caffeine within 48 hours before the first dose, or other special diets that could affect drug pharmacokinetics.
- 21.History of drug abuse, drug usage, or positive drug screening within one year before signing the ICF.
- 22.Chronic Alcohol Consumption: Males > 14 units/week, females > 7 units/week (1 unit ≈ 10g pure alcohol).
- 23.History of needle phobia or blood phobia judged by the investigator to be clinically significant.
- 24.Known or suspected hypersensitivity to the study drug or any of its components.
- 25.Female Status: Women who are pregnant, breastfeeding, or planning to become pregnant (excludes those postmenopausal for ≥ 1 year or surgically sterilized).
- 26.Other conditions that the investigator deems unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Two-period, Crossover, Steady-state Bioequivalence Study of Aripiprazole for Injection Following Multiple Dosing in Patients With Schizophrenia
The primary objective of this study is to evaluate the bioequivalence of aripiprazole for injection (Test product, 400 mg) compared with Abilify Maintena® (Reference product, 400 mg) at steady state in patients with schizophrenia.his is a multi-center, randomized, open-label, two-period, crossover study. Approximately 116 clinically stable patients will be enrolled and randomly assigned to one of two treatment sequences: Sequence A (Test-Reference) or Sequence B (Reference-Test). In each 141-day study period, participants will receive five injections of either the test or reference product at 28-day intervals to achieve steady-state plasma concentrations. Bioequivalence, safety and tolerability of the study drug will be assessed in this study.
Read the detailed description
Purpose: The primary objective of this study is to evaluate the steady-state bioequivalence between Aripiprazole for Injection (400 mg) manufactured by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (Test product) and Abilify Maintena® (400 mg) manufactured by Otsuka Pharmaceutical (Reference product) in Chinese patients with stable schizophrenia.
Methods: This is a multicenter, randomized, open-label, two-period, crossover, multiple-dose,steady-state bioequivalence study. Approximately 116 eligible patients with stable schizophrenia will be randomly assigned to one of two treatment sequences (Test-Reference or Reference-Test). In each period, subjects will receive five intramuscular injections of either the Test or Reference product (400 mg) at 28-day intervals to ensure that steady-state blood concentrations are achieved by the fourth dose.
Primary Endpoints: Pharmacokinetic (PK) samples will be collected to determine the steady-state maximum plasma concentration (Cmax,ss) and the area under the plasma concentration-time curve over the dosing interval at steady state (AUCτ,ss).
Safety: The safety and tolerability of both formulations will also be monitored and compared throughout the trial.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole for Injection
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole for InjectionDrug
Also called SYH9096
Subjects will receive a dose of 400 mg (approximately 2 mL) of the test product. The medication is administered via deep intramuscular injection into the gluteal muscle once every 28 days (±1 day). In each study period, subjects will receive a total of 5 injections to ensure steady-state concentrations are achieved.
Aripiprazole for InjectionDrug
Also called Abilify Maintena®
Subjects will receive a dose of 400 mg (400 mg/2 mL) of the reference product. The medication is administered via deep intramuscular injection into the gluteal muscle once every 28 days (±1 day). In each study period, subjects will receive a total of 5 injections to maintain consistent exposure levels for bioequivalence comparison.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (Test - Reference) | Experimental | Participants receive the Test product (400 mg) in Period 1 and the Reference product (400 mg) in Period 2. Receives: Drug: Aripiprazole for Injection |
| Sequence B (Reference - Test) | Active comparator | Participants receive the Reference product (400 mg) in Period 1 and the Test product (400 mg) in Period 2. Receives: Drug: Aripiprazole for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state Maximum Plasma Concentration (Cmax,ss) of Aripiprazole
The observed maximum concentration of aripiprazole in plasma at steady state following the 5th intramuscular injection (400 mg) in each study period
Measured: Period 1: Day 113 to Day 141 ; Period 2: Day 253 to Day 281
Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady State (AUCτ,ss) of Aripiprazole.
The area under the plasma concentration-time curve for aripiprazole calculated over a dosing interval (28 days) at steady state using the linear up-log down rule.
Measured: Period 1: Day 113 to Day 141 ; Period 2: Day 253 to Day 281
Secondary outcomes (14)
Time to Maximum Plasma Concentration (Tmax,ss) of Aripiprazole at Steady State.
The time to reach the maximum observed plasma concentration of aripiprazole after multiple dosing at steady state.
Measured: Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281
Trough Plasma Concentration (Ctau,ss) of Aripiprazole at Steady State.
The plasma concentration measured at the end of a dosing interval at steady state.
Measured: Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281
Minimum Plasma Concentration (Cmin,ss) of Aripiprazole at Steady State.
The minimum observed plasma concentration during a dosing interval at steady state.
Measured: Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281
Terminal Elimination Half-life (t1/2,ss) of Aripiprazole at Steady State.
The time required for the plasma concentration of aripiprazole to decrease by half during the terminal phase at steady state.
Measured: Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281.
Fluctuation Factor (DF) of Aripiprazole at Steady State.
(Cmax,ss-Cmin,ss)/ Cav,ss
Measured: Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281.
Steady-state Average Concentration (Cav,ss) of Aripiprazole.
Average concentration at steady state.
Measured: Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281.
Terminal Elimination Rate Constant (λz,ss) of Aripiprazole at Steady State.
The rate at which aripiprazole is removed from the body.
Measured: Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281.
Swing of Aripiprazole at Steady State.
(Cmax,ss-Cmin,ss)/ Cmin,ss.
Measured: Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281.
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Assessment of safety and tolerability by monitoring the frequency and severity of AEs, SAEs, and changes in laboratory tests, 12-lead ECG, physical examinations, and vital signs.
Measured: Day1 to Day281.
CGI Score
The CGI-S is a 7-point scale that measures the clinician's assessment of the severity of the patient's mental illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Day1 to Day281.
C-SSRS
The Columbia-Suicide Severity Rating Scale (C-SSRS) assesses suicidal ideation and behavior.
Measured: Day1 to Day281
BARS Score
The BARS is used to assess the severity of drug-induced akathisia. The Global Clinical Assessment score ranges from 0 (absent) to 5 (severe).
Measured: Day1 to Day281
AIMS Score
The AIMS is used to assess the presence and severity of tardive dyskinesia. The total score is the sum of items 1 through 7, with each item rated from 0 (none) to 4 (severe).
Measured: Day1 to Day281
SAS Score
The SAS is used to assess extrapyramidal symptoms. It consists of 10 items, each rated on a 5-point scale (0 to 4).
Measured: Day1 to Day281
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start5 Apr 2026 (estimated)
- Primary completion5 Sep 2027 (estimated)
- Study completion5 Nov 2027 (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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a multicenter, randomized, open-label, two-period, crossover, multiple-dose steady-state bioequivalence study. Approximately 116 eligible Chinese patients with stable schizophrenia will be randomly assigned to one of two treatment sequences: Sequence A (Test product followed by Reference product) or Sequence B (Reference product followed by Test product).In each study period, participants will receive five intramuscular injections of the assigned product (400 mg) at 28-day intervals.
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547384
- Sponsor's protocol ID
- SYH9096-001
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No