A multicentre, randomized,open label,two-period, two-treatment,two-way crossover, bioequivalence study comparing Temozolomide capsules 250 mg (Manufactured by: Fresenius Kabi Oncology Limited, India) to the reference listed drug Temodal (Temozolomide) Capsules 250 mg (Manufactured by: Orion Corporation, Orion Pharma Division, Turku, Finland, Distributed by Schering-Plough Products Pharmaceuticals Ltd.,Brazil) in Glioblastoma Multiforme or Anaplastic Astrocytoma patients under fasting condition.

Trial Profile

A multicentre, randomized,open label,two-period, two-treatment,two-way crossover, bioequivalence study comparing Temozolomide capsules 250 mg (Manufactured by: Fresenius Kabi Oncology Limited, India) to the reference listed drug Temodal (Temozolomide) Capsules 250 mg (Manufactured by: Orion Corporation, Orion Pharma Division, Turku, Finland, Distributed by Schering-Plough Products Pharmaceuticals Ltd.,Brazil) in Glioblastoma Multiforme or Anaplastic Astrocytoma patients under fasting condition.

Completed
Phase of Trial: Phase I

Latest Information Update: 30 Aug 2016

At a glance

  • Drugs Temozolomide (Primary)
  • Indications Anaplastic astrocytoma; Glioblastoma
  • Focus Pharmacokinetics
  • Sponsors Fresenius Kabi
  • Most Recent Events

    • 18 Sep 2013 Status changed from recruiting to completed as reported by Clinical Trials Registry - India.
    • 28 Jan 2013 Planned end date changed from 4 Oct 2013 to 17 Dec 2013 as reported by Clinical Trials Registry - India record.
    • 02 Oct 2012 New trial record
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