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

Exclusion Criteria

• •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.
• •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.