Schizophrenia Clinical Trial
Official title:
An Open-Label Study Changing Generic Clozapine Formulation to FazaClo® (Clozapine, USP) Orally Disintegrating Tablets in Stable Patients With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo (orally disintegrating tablet). Generic clozapine is the most frequently used clozapine and such data is important for clinicians to have.
The primary objective of this study is to determine the equivalence of generic clozapine
tablets to FazaClo in patients with schizophrenia or schizoaffective disorder who are
already taking generic clozapine and are switched to FazaClo.
In this study, patients receiving a stable twice-daily dose of generic clozapine formulation
for the past one month will be switched to FazaClo. A trough steady-state clozapine and
desmethylclozapine concentrations will be taken thrice while patient is on generic
Clozapine. After the third clozapine level patients will be switched from their generic
clozapine formulation to FazaClo, at the same dosage and treatment regimen as the generic
clozapine formulation they had been receiving. Trough steady-state clozapine and
desmethylclozapine concentration levels will be taken twice, 7 days and 14 days after
starting Fazaclo.
;
Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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