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.
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
- 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