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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Steady-state Maximum Plasma Concentration (Cmax,ss) of Aripiprazole
Timeframe: Period 1: Day 113 to Day 141 ; Period 2: Day 253 to Day 281
Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady State (AUCÏ„,ss) of Aripiprazole.
Timeframe: Period 1: Day 113 to Day 141 ; Period 2: Day 253 to Day 281
Clinical Trials Information Group officer