Fed Bioavailability Study of Zonisamide Capsules
Condition: Healthy
Intervention: Zonisamide 100 mg Capsule; Zonisamide (Zonegran®) 100 mg Capsule
Intervention description: 100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.; 100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.
Intervention MeSH terms: Zonisamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Therapeutic Equivalency

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.
    

Eligibility criteria:

        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.