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.

Trial Profile

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.

Completed
Phase of Trial: Phase II

Latest Information Update: 30 Aug 2016

At a glance

  • Drugs Clozapine (Primary)
  • Indications 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top