A Bioequivalence Study of PP3M in Patients With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/m² (including 19.0 and 35.0).
Positive and Negative Syndrome Scale (PANSS) total score lower than 70 at screening and baseline.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Paliperidone Palmitate Injection (3M)
DrugIntramuscular injection
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: Test productActive comparator 1 intervention
Group B: Reference productActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cmax,ss,
Maximum plasma concentration at steady state
Time frame
Up to Day4562
AUCτ,ss
Area under the plasma concentration-time curve over a dosing interval at steady state
Time frame
Up to Day456Secondary outcomes
1
Title:Incidence and severity of adverse events (AEs)
The frequency and degree of harmfulness of adverse events
Time frame
Up to Day456Sponsors and contacts
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Source ClinicalTrials.gov