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

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.