drugset / Trial / NCT00908453

The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin

NCT00908453

Phase 3 Completed 40 enrolled Nobelpharma
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who are requiring a loading dose of phenytoin.

Timeline

Start
2009-05
Primary completion
2010-02
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Fosphenytoin Small molecule 15 mg/kg Intravenous
Subject Fosphenytoin Small molecule 18 mg/kg Intravenous
Subject Fosphenytoin Small molecule 22.5 mg/kg Intravenous

Indications