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RECRUITING
NCT07493551
NA

A Bioequivalence Study of PP3M in Patients With Schizophrenia

Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2024-10-09

Completion Date

2026-12-31

Last Updated

2026-03-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Paliperidone Palmitate Injection (3M)

Intramuscular injection

Locations (1)

Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, China