Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients
The aims of this study are to determine, in adult patients on maintenance topiramate therapy, the steady-state pharmacokinetics and safety of orally and intravenously administered topiramate.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Pharmacokinetic and Safety Study of Intravenous Topiramate in Adult Patients|
- Pharmacokinetics [ Time Frame: 96 hours after dosing ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
This is a one arm pharmacokinetic and safety study.
Drug: intravenous topiramate
Single 25 mg IV dose given in addition to subject's normal morning dose of topiramate
Other Name: Topamax
The long-term goal of this research project is to develop a more effective, safer therapy for neonatal seizures. Prior to using an investigational intravenous topiramate formulation in children and neonates, the pharmacokinetics and safety of the formulation must be demonstrated in adults. The immediate aims of this study are to determine the pharmacokinetics and safety of a novel intravenous topiramate formulation. An additional aim is to determine if sex, advancing age, or genotype affects topiramate absorption, distribution, or elimination.
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||James C Cloyd, PharmD||University of Minnesota - Clinical and Translational Science Institute|