Steady-state Bioequivalence Study of Aripiprazole for Injection in Patients With Schizophrenia.

NCT07547384 | Not Yet Recruiting

• 1 other identifier: SYH9096-001
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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.

  Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281

• Trough Plasma Concentration (Ctau,ss) of Aripiprazole at Steady State.

  Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281

• Minimum Plasma Concentration (Cmin,ss) of Aripiprazole at Steady State.

  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.

  Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281.

• Fluctuation Factor (DF) of Aripiprazole at Steady State.

  Period 1: Day 113 to Day 141; Period 2: Day 253 to Day 281.

Study Arms (2)

Sequence A (Test - Reference)

EXPERIMENTAL

Participants receive the Test product (400 mg) in Period 1 and the Reference product (400 mg) in Period 2.

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.

Drug: Aripiprazole for Injection

Interventions

Aripiprazole for Injection DRUG

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.

Also known as: SYH9096

Sequence A (Test - Reference); Sequence B (Reference - Test)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18 to 65 years (inclusive), male or female.
• \. 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).
• \. 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).
• \. Body weight ≥ 45 kg for females and ≥ 50 kg for males; Body Mass Index (BMI) between 18.5 and 35.0 kg/m² (inclusive).
• \. 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.
• \. Subjects and their legal guardians voluntarily sign the Informed Consent Form (ICF) and are able to comply with all study requirements.

You may not qualify if:

• Diagnosis of any psychiatric disorder other than schizophrenia according to ICD-10 criteria.
• 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.
• Patients with Parkinson's disease, Lewy body dementia, or dementia-related psychosis.
• History or presence of Neuroleptic Malignant Syndrome (NMS).
• 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).
• Concurrent tardive dyskinesia (or history) or severe akathisia.
• Esophageal motility dysfunction or dysphagia with a potential risk of aspiration pneumonia.
• 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.
• 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).
• Glycosylated hemoglobin (HbA1c) level ≥ 7% at screening or baseline.
• 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.
• Positive results for HBsAg, HCV-Ab, HIV-Ab, or Syphilis-Ab that, in the investigator's judgment, affect study participation.
• 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.
• Received electroconvulsive therapy (ECT) or invasive psychiatric treatment within 28 days before signing the ICF.
• History of Blood Loss: Blood loss ≥ 400 mL within 3 months or ≥ 200 mL within 1 month before signing the ICF.

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole; Injections

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 23, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): September 5, 2027
• Study Completion (Estimated): November 5, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-03