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A Bioequivalence Study of PP3M in Patients With Schizophrenia
Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
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
Paliperidone Palmitate Injection (3M)
Intramuscular injection
Locations (1)
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, China