A Bioequivalence Study of PP3M in Patients With Schizophrenia

CSPC Pharmaceutical Group

Status: Enrolling

Conditions: Schizophrenia

Treatments: Drug: Paliperidone Palmitate Injection (3M)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07493551

SYHF2037-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

260 participants in 2 patient groups

Test product

Active Comparator group

Description:

Paliperidone Palmitate Injection (3M), 1.75 mL: 350 mg

Treatment:

Drug: Paliperidone Palmitate Injection (3M)

Reference product

Active Comparator group

Description:

Invega Trinza, 1.75 mL: 350 mg

Treatment:

Drug: Paliperidone Palmitate Injection (3M)