A Study of the Pharmacokinetics (PK) and Safety of IV Carbamazepine Relative to Oral Carbamazepine in Adults With Epilepsy

PHASE1CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

April 30, 2009

Conditions
Epilepsy
Interventions
DRUG

Intravenous Carbamazepine

10 mg/mL of intravenous Carbamazepine (CBZ) dissolved in 250 mg/mL of Captisol® (cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by intravenous infusion every 6 hours.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Lundbeck LLC

INDUSTRY