Schizophrenia
Conditions
Brief 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.
Interventions
DRUGPaliperidone Palmitate Injection (3M)
Intramuscular injection
Sponsors
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, multicenter, two-formulation, multiple-dose, parallel-design study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 65 years old (including 18 and 65 years old). * Patients diagnosed with schizophrenia (by ICD-10 criteria) before screening. * Weight: male patients with weight ≥50.0 kg, female patients with weight ≥45.0 kg, with the body mass index of 19.0\~35.0 kg/m\^2 (including 19.0 and 35.0). * Positive and Negative Syndrome Scale (PANSS) total score lower than 70 at screening and baseline. * Clinical Global Impression-Severity (CGI-S) lower than 4 at screening and baseline. * Patients and their guardians voluntarily sign the ICF and are able to comply with the requirements of the study.
Exclusion criteria
* Be allergic, or have a clear history of allergies to trial drugs and components. * Patients with cardiovascular, liver, kidney, gastrointestinal, psychiatric, or neurological diseases that may affect participation in the trial, as determined by the investigator. * History of tardive dyskinesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,ss, | Up to Day456 | Maximum plasma concentration at steady state |
| AUCτ,ss | Up to Day456 | Area under the plasma concentration-time curve over a dosing interval at steady state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Title:Incidence and severity of adverse events (AEs) | Up to Day456 | The frequency and degree of harmfulness of adverse events |
Countries
China
Contacts
CONTACTClinical Trials Information Group officer
PRINCIPAL_INVESTIGATORGang Wang, M.D.
Beijing Anding Hospital Capital Medical University
Outcome results
None listed