NCT00687167

Fed Bioavailability Study of Zonisamide Capsules

A Relative Bioavailability Study of 100 mg Zonisamide Capsules Under Non-Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Mutual Pharmaceutical Company, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions.

Detailed description

The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions. Thirty-four healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zonisamide dosing regimens in sequence with a 28 day washout period between dosing periods. On the morning of Day 1, 30 minutes after initiation of a standardized, high-fat breakfast, subjects will receive either a single oral dose of the test formulation, zonisamide (1 x 100 mg capsule) or a single oral dose of the reference formulation, Zonegran® (1 x 100 mg capsule). After a 28 day washout period, on the morning of Day 29, 30 minutes after initiation of a standardized, high-fat breakfast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of zonisamide. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following dose administration. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zonisamide 100 mg Capsule	100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.
DRUG	Zonisamide (Zonegran®) 100 mg Capsule	100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2008-05-30
• Last updated: 2010-01-26
• Results posted: 2009-12-30

Locations

1 site across 1 country: United States