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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Intramuscular injection
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGCmax,ss,
Maximum plasma concentration at steady state
Time frame: Up to Day456
AUCτ,ss
Area under the plasma concentration-time curve over a dosing interval at steady state
Time frame: Up to Day456
Title:Incidence and severity of adverse events (AEs)
The frequency and degree of harmfulness of adverse events
Time frame: Up to Day456
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.