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

Sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Study ID
NCT07547384
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Aripiprazole for Injection — DRUG
    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.
  • Aripiprazole for Injection — DRUG
    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.

Study Details

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.

Key Dates

First listed
Apr 23, 2026
Start date
Apr 5, 2026
Status verified
Mar 2026
Primary completion
Sep 5, 2027
Completion
Nov 5, 2027

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Sequence A (Test - Reference)
    Participants receive the Test product (400 mg) in Period 1 and the Reference product (400 mg) in Period 2.
  • Active Comparator: Sequence B (Reference - Test)
    Participants receive the Reference product (400 mg) in Period 1 and the Test product (400 mg) in Period 2.

Primary Outcome Measure

Steady-state Maximum Plasma Concentration (Cmax,ss) of Aripiprazole [ Time Frame: Period 1: Day 113 to Day 141 ; Period 2: Day 253 to Day 281 ]

Central Contacts

Find similar trials

Nationwide
Schizophrenia trialsPsychiatry trialsMental health trialsBehavioral health trials

Related Studies