Steady-state Bioequivalence Study of Aripiprazole for Injection in Patients With Schizophrenia.
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.
detailed description
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.
official title
A Randomized, Open-label, Two-period, Crossover, Steady-state Bioequivalence Study of Aripiprazole for Injection Following Multiple Dosing in Patients With Schizophrenia