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.