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NOT YET RECRUITING
NCT07547384
NA

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

Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2026-04-05

Completion Date

2027-11-05

Last Updated

2026-04-23

Healthy Volunteers

No

Conditions

Interventions

DRUG

Aripiprazole for Injection

Subjects 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.

DRUG

Aripiprazole for Injection

Subjects 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.