Sanaclis-PLPP

Sanaclis-PLPP is a randomized, open-label, two-treatment, two-period, two sequence, multiple-dose, cross-over design, multi-center comparative bioavailability study. This is a laboratory-blind study. Subjects are not blinded, and the Positive and Negative Syndrome Scale (PANSS), Extrapyramidal Symptoms Rating Scale (ESRS) and Columbia Suicide Severity Rating Scale (C-SSRS) interviewer is blinded. The study population will consist of male and female patients with schizophrenia on paliperidone palmitate therapy from the general population.

Primary objective

To evaluate the comparative bioavailability between:

• paliperidone prolonged release suspension for injection 75 mg from Teva Pharmaceutical Industries, Ltd., Israel, and
• Xeplion® 75 mg prolonged release suspension for injection from Janssen-Cilag International N.V., Belgium

after multiple doses in subjects with schizophrenia on paliperidone palmitate therapy.

Secondary objective

To evaluate the safety and tolerability following administration of study treatment in subjects with schizophrenia on paliperidone palmitate therapy