NCT07268430

Bioequivalence Study of Long-Acting Paliperidone Palmitate in Patients With Schizophrenia

A Multicenter, Randomized, Open-Label, Parallel-Group, Multiple-Dose Bioequivalence Study of Paliperidone Palmitate Injection in Chinese Patients With Schizophrenia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, open-label, parallel-group, multiple-dose study is designed to evaluate the bioequivalence, at pharmacokinetic steady state, of a paliperidone palmitate injection manufactured by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (Test Group) and a paliperidone palmitate injection manufactured by Janssen Pharmaceutica N.V. (Reference Group) in patients with schizophrenia in China. Bioequivalence will be assessed based on steady-state pharmacokinetic parameters after repeated intramuscular administration (e.g., Cmax,ss and AUCτ). The safety and tolerability of the test and reference products will also be evaluated.

Detailed description

Purpose: This trial was conducted to evaluate the bioequivalence of a test (T) and a reference (R) formulation of once-monthly paliperidone palmitate (PP1M) in patients with schizophrenia. Patients and methods: In this randomized, open-label, parallel-group, steady-state bioequivalence study, patients with stabilized schizophrenia were randomized 1:1 to receive T or R formulation. The regimen was 150 mg deltoid on Day 1, then 100 mg deltoid on Day 8, followed by five subsequent 100 mg gluteal injections every 28 days. The primary objective was to demonstrate steady-state bioequivalence. The primary endpoints were key pharmacokinetic parameters of paliperidone, including steady-state maximum concentration (Cmax,ss) and the area under the concentration-time curve over a dosing interval at steady state (AUCτ,ss). Bioequivalence was shown if the 90% confidence interval (CI) for the ratio of the geometric least squares means of the pharmacokinetic parameters (AUCτ,ss and Cmax,ss) fell within 80%-125%.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperidone Palmitate Injection(PP1M)	Paliperidone palmitate injection will be administered intramuscularly according to two dosing regimens based on participants' prior exposure to paliperidone palmitate: 1. Participants with no prior use of paliperidone palmitate injection, or whose last dose was administered more than 6 months ago (for the once-monthly formulation), or more than 5 half-lives ago (for the once-every-3-months formulation): Day 1: 150 mg, deltoid muscle Day 8: 100 mg, deltoid muscle Followed by 100 mg every 28 days thereafter Approximate treatment duration: 148 days 2. Participants who have previously received at least 3 injections (including 150 mg Day 1 loading dose and 100 mg Day 8 loading dose, deltoid muscle) of the once-monthly formulation (100 mg) of paliperidone palmitate and whose last dose was given within 4 to 6 weeks prior to enrollment: Continue with 100 mg every 28 days Approximate treatment duration: 113 days
DRUG	Paliperidone Palmitate Injection(PP1M)(Reference Group)	Paliperidone palmitate injection will be administered intramuscularly according to two dosing regimens based on participants' prior exposure to paliperidone palmitate: 1. Participants with no prior use of paliperidone palmitate injection, or whose last dose was administered more than 6 months ago (for the once-monthly formulation), or more than 5 half-lives ago (for the once-every-3-months formulation): Day 1: 150 mg, deltoid muscle Day 8: 100 mg, deltoid muscle Followed by 100 mg every 28 days thereafter Approximate treatment duration: 148 days 2. Participants who have previously received at least 3 injections (including 150 mg Day 1 loading dose and 100 mg Day 8 loading dose, deltoid muscle) of the once-monthly formulation (100 mg) of paliperidone palmitate and whose last dose was given within 4 to 6 weeks prior to enrollment: Continue with 100 mg every 28 days Approximate treatment duration: 113 days

Timeline

• Start date: 2023-12-18
• Primary completion: 2024-12-25
• Completion: 2024-12-25
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: China