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Bioequivalence to Clozaril® The relative bioavailability of FazaClo® (clozapine, USP) 100 mg administered without liquids was compared to a 100 mg Clozaril® tablet administered with liquid in a randomized, open-label, multiple dose, two-way crossover study in 33 patients with schizophrenia. Patients were not currently acutely exacerbated or considered treatment-resistant. The results of the study demonstrated that FazaClo tablets are bioequivalent to Clozaril tablets following multiple (bid) doses in patients with schizophrenia and that FazaClo can be administered without the need for any liquid. Desmethylclozapine, a metabolite of clozapine, was also bioequivalent between the two treatments. Both FazaClo and Clozaril were tolerated similarly and the incidence of drug-related adverse events was similar between the two. Therefore FazaClo may be substituted for Clozaril tablets on a milligram for milligram basis.
Clozaril® is a registered trademark of Novartis Pharmaceuticals Corporation. |
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