Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg

Inclusion criteria

• Age: 18 years and older.
• Sex: Male.
• Weight: At least 60 kg (132 lbs) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
• All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Exclusion criteria

• Institutionalized subjects will not be used.
• Social Habits:

• Use of any tobacco products within 1 year of the start of the study.
• Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
• Ingestion of any vitamins or herbal products within the 7 days prior to the initial dose of the study medication.
• Any recent, significant change in dietary or exercise habits.
• A positive test for any drug included in the urine drug screen.
• History of drug and/or alcohol abuse.
• Medications:

• Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
• Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
• Diseases:

• History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
• Acute illness at the time of either the pre-study medical evaluation or dosing.
• A positive HIV, hepatitis B, or hepatitis C test.
• Abnormal and clinically significant laboratory test results:

• Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
• Abnormal and clinically relevant ECG tracing.
• Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
• Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
• Allergy or hypersensitivity to zonisamide or any other sulfa drugs.
• History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
• Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.