Who is sponsoring NCT01079351?

NCT01079351 is sponsored by Lundbeck LLC.

What drugs are being tested in NCT01079351?

Interventions: Intravenous Carbamazepine.

What is the status of NCT01079351?

NCT01079351 is currently COMPLETED.

Last reviewed 2010-04-22 · How we verify

A Sequential, Open-Label Study of the Pharmacokinetics and Safety of Intravenous Carbamazepine Relative to Oral Carbamazepine in Adult Patients With Epilepsy

NCT01079351 Phase 1 COMPLETED

The purpose of this study is to assess the safety, tolerability and steady-state pharmacokinetics of intravenous (IV) Carbamazepine (CBZ) infusions relative to orally administered CBZ in adult patients with epilepsy.

Details

Lead sponsor	Lundbeck LLC
Phase	Phase 1
Status	COMPLETED
Enrolment	98
Start date	2007-04
Completion	2009-04

Conditions

Epilepsy

Interventions

Intravenous Carbamazepine

Primary outcomes

To assess the safety, tolerability and pharmacokinetics of IV CBZ as a 30- and 15-minute infusion relative to orally administered CBZ in adult patients with epilepsy. — 31 days
To compare the steady-state pharmacokinetics of intravenously administered CBZ (Day 7) relative to orally administered CBZ (Day 0). — Day 7