Multicenter open-label randomized crossover bioequivalence study of BCD-029 (CJSC Biocad, Russia) and Temodal (Schering-Plough Labo N.V.) in capsules after single oral administration (under fasting conditions) in patients with progressive or recurrent malignant glioma or advanced metastatic malignant melanoma.

Trial Profile

Multicenter open-label randomized crossover bioequivalence study of BCD-029 (CJSC Biocad, Russia) and Temodal (Schering-Plough Labo N.V.) in capsules after single oral administration (under fasting conditions) in patients with progressive or recurrent malignant glioma or advanced metastatic malignant melanoma.

Completed
Phase of Trial: Phase I

Latest Information Update: 31 Aug 2016

At a glance

  • Drugs Temozolomide (Primary)
  • Indications Glioma; Malignant melanoma
  • Focus Pharmacokinetics
  • Sponsors Biocad
  • Most Recent Events

    • 13 Jan 2014 Status changed from active, no longer recruiting to completed as per Clinical Trials Registry - India record.
    • 20 Jun 2013 New trial record
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