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.
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
- 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