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.
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).
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).