Fed Bioavailability Study of Zonisamide Capsules

Inclusion Criteria

• Screening Demographics:
• All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing
• Weight range will not exceed ± 20% for height and body frame
• Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing
• Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures
• Screening will include general observation, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature
• The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems
• The screening clinical laboratory procedures will include: Hematology, Clinical Chemistry, HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody, Urinalysis, Urine Drug Screen, Serum Pregnancy Screen, Follicle Stimulating Hormone
• If female: postmenopausal for 1 year or surgically sterile.

Exclusion Criteria

• Volunteers with a recent history of drug or alcohol addiction or abuse
• Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease
• Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant
• Volunteers demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody screen
• Volunteers demonstrating a positive drug abuse screen when screened for this study
• Female volunteers demonstrating a positive pregnancy screen
• Female volunteers who are currently breastfeeding
• Volunteers with a history of allergic response(s) to zonisamide or related drugs
• Volunteers with a history of clinically significant allergies including drug allergies
• Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigator)
• Volunteers who currently use tobacco products
• Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing
• Volunteers who report donating greater than 150mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study
• Volunteers who report receiving any investigational drug within 14 days prior to Period I dosing.
• Volunteers who have donated plasma(e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study
• Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing.