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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07547384
Lead Sponsor CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Conditions
(from sponsor)		 Schizophrenia
Related terms Schizophrenia
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov