NCT07493551

A Bioequivalence Study of PP3M in Patients With Schizophrenia

A Randomized, Open-label, Multicenter, Two-formulation, Multiple-dose, Parallel-design Bioequivalence Study of Paliperidone Palmitate Injection (3M) in Chinese Patients With Schizophrenia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the bioequivalence of the test formulation paliperidone palmitate injection (3M) produced by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. and the reference formulation paliperidone palmitate injection (3M) (brand name: Invega Trinza) by Janssen Pharmaceutica N.V. under multiple-dose administration.

Detailed description

A randomized, open-label, multi-center, two-drug, multiple-dose, parallel-design study was conducted among patients with schizophrenia in China to evaluate the bioequivalence of the test formulation paliperidone palmitate (3M) produced by CSPC zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. and the reference formulation paliperidone palmitate injection (3M) (trade name: Santodar) of Janssen Pharmaceutica N.V.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperidone Palmitate Injection (3M)	Intramuscular injection

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: China