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A multicenter, open-label, randomized, two-treatment, two- sequence, two-period, cross-over, steady-state clinical Bio-equivalence study of Clozapine 100 mg tablet of Aurobindo (test) with Clozaril (Clozapine) 100 mg tablet of Novartis (reference) in schizophrenic patients already receiving/ stabilized with Clozapine under fasting conditions.

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A multicenter, open-label, randomized, two-treatment, two- sequence, two-period, cross-over, steady-state clinical Bio-equivalence study of Clozapine 100 mg tablet of Aurobindo (test) with Clozaril (Clozapine) 100 mg tablet of Novartis (reference) in schizophrenic patients already receiving/ stabilized with Clozapine under fasting conditions.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Clozapine (Primary)
  • Indications Schizoaffective disorder; Schizophrenia
  • Focus Pharmacokinetics
  • Sponsors Aurobindo Pharma

    • Most Recent Events

    • 27 Nov 2013 Status changed from recruiting to completed as reported by Clinical Trials Registry - India record.
    • 05 Jul 2013 New trial record
    • 20 Jun 2013 Status changed from not yet recruiting to recruiting as reported by Clinical Trials Registry - India record.

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