A multicentric open label, balanced, randomized, two treatment, two-period, two-sequence, crossover, steady state bioequivalence evaluation of clozapine tablet 100 mg twice daily (test drug) with Clozaril® 100 mg tablets twice daily (reference drug, Novartis pharmaceuticals corporation, USA) after multiple dose administration in adult schizophrenic patients under fasting conditions

The Sponsor has developed tablet formulation of clozapine. As a high number of healthy subjects experienced serious adverse effects after administration of antipsychotics such as hypotension, tachycardia etc., regulatory authorities recommend that pharmacokinetic study of clozapine should be conducted on schizophrenic patients. The objective of the present study is to assess and compare the bioavailability and to characterize the pharmacokinetic profile of the Sponsor’s formulation (Clozapine tablet 100 mg, twice daily) with respect to the reference formulation (ClozarilPrinston Pharmaceutical Inc., USA or Clozaril® of Novartis Pharmaceuticals Corporation, USA, 100 mg tablets twice daily) in schizophrenic patients stabilized on clozapine 200 mg per day under fasting condition. Through this study, we will prospectively collect the data from adult schizophrenic patients who will be randomly assigned to receive either clozapine 100 mg tablet of ® (Novartis Pharmaceuticals Corporation, USA) for the pharmacokinetic profiling.