Status:
COMPLETED
Fasting Bioavailability Study of Zonisamide Capsules
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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) ...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00685139
Start Date
January 1 2005
End Date
March 1 2005
Last Update
January 26 2010
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