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Clinical trial

A Randomized, Open Label, Two-way Crossover, Single Dose Bioequivalence Study Comparing Dralitem® Capsules to the Reference Drug Temodal® Capsules in Patients With Primary Tumors of the Central Nervous System Under Fasting Conditions

NCT02343081 is registered in ClinicalTrials.gov with Monte Verde SA as lead sponsor.

NCT NCT02343081
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Open Label, Two-way Crossover, Single Dose Bioequivalence Study Comparing Dralitem® Capsules to the Reference Drug Temodal® Capsules in Patients With Primary Tumors of the Central Nervous System Under Fasting Conditions
Lead sponsor
Monte Verde SA
Phase
Phase 4
Overall status
Completed
Start date
January 31, 2012
Completion date
October 31, 2013
Enrollment
24 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

brain neoplasms, malignant, primary