Conditions: Healthy
Keywords: Therapeutic Equivalency
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 34
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: A single dose of zonisamide 100 mg administered 30 minutes after initiation of a standardized, high fat breakfast. arm 2: A single dose of Zonegran® 100 mg administered 30 minutes after initiation of a standardized, high fat breakfast.

Interventions: intervention 1: Zonisamide 100 mg Capsule intervention 2: Zonisamide (Zonegran®) 100 mg Capsule
Intervention descriptions: intervention 1: 100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast. intervention 2: 100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.

Protocol document: