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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nobelpharma
• Treatments: Fosphenytoin; Phenytoin

Criteria

Inclusion Criteria:

• male or female, hospitalized patients 2 years of age or older

• Adult patients or guardian for pediatric patients to provide written informed consent

Exclusion Criteria:

• patient with a history of hypersensitivity to hydantoins

• patient with hypotension, sinus bradycardia, sino-atrial block, second or third degree A-V block, or Adams-Stokes syndrome

• pregnant or nursing female patients