A Bioequivalence Study of PP3M in Patients With Schizophrenia
Recruiting
N/A
Interventional Study
Schizophrenia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 260 (estimated)
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
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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.
Trial Locations
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Eligibility Criteria
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…
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