An open label, balanced, randomized, two treatment, two-period, two-sequence, crossover, multicentric experimental comparative evaluation of Clozapine modified release capsule 200 mg once daily (Test drug, Intas Pharmaceuticals Ltd., India) with Leponex 100 mg tablets twice daily (Reference drug, Novartis Farmaceutica, S.A Spain), under fasting conditions after multiple dose administration at steady state in adult schizophrenic patients stabilized on Clozapine 200 mg per day.

Trial Profile

An open label, balanced, randomized, two treatment, two-period, two-sequence, crossover, multicentric experimental comparative evaluation of Clozapine modified release capsule 200 mg once daily (Test drug, Intas Pharmaceuticals Ltd., India) with Leponex 100 mg tablets twice daily (Reference drug, Novartis Farmaceutica, S.A Spain), under fasting conditions after multiple dose administration at steady state in adult schizophrenic patients stabilized on Clozapine 200 mg per day.

Completed
Phase of Trial: Phase I

Latest Information Update: 30 Aug 2016

At a glance

  • Drugs Clozapine (Primary)
  • Indications Schizophrenia
  • Focus Pharmacokinetics
  • Sponsors Intas Pharmaceuticals
  • Most Recent Events

    • 06 Apr 2010 New trial record
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