The purpose of this study is to evaluate and compare the relative bioavailability of a test
formulation of zonisamide capsules to an equivalent dose of a reference formulation,
Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting
conditions.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.