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).
Crossover
Aripiprazole for Injection
DrugSubjects 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 Injection
DrugSubjects 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.
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
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.
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.
Trough Plasma Concentration (Ctau,ss) of Aripiprazole at Steady State.
The plasma concentration measured at the end of a dosing interval at steady state.
Minimum Plasma Concentration (Cmin,ss) of Aripiprazole at Steady State.
The minimum observed plasma concentration during a dosing interval at steady state.
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.
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