Overview

Fasting Bioavailability Study of Zonisamide Capsules

Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Treatments:
Zonisamide
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.