U.S., April 24 -- ClinicalTrials.gov registry received information related to the study (NCT07547384) titled 'Steady-state Bioequivalence Study of Aripiprazole for Injection in Patients With Schizophrenia.' on March 23.
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(R) (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 perio...