Bioequivalence Study of Long-Acting Paliperidone Palmitate in Patients With Schizophrenia
Status:
COMPLETED
Trial end date:
2024-12-25
Target enrollment:
Participant gender:
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 AUC). The safety and tolerability of the test and reference products will also be evaluated.