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Fasting Bioavailability Study of Zonisamide Capsules
This study has been completed.
Sponsored by: Mutual Pharmaceutical Company, Inc.
Information provided by: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00685139
  Purpose

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 Zonegran Capsules in healthy adult subjects under fasting conditions


Condition Intervention Phase
Therapeutic Equivalency
Drug: zonisamide
Phase I

Drug Information available for: Zonisamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind (Investigator), Crossover Assignment, Bio-equivalence Study
Official Title: A Relative Bioavailability Study of 100mg Zonisamide Capsules Under Fasting Conditions

Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: January 2005
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
One 100mg capsule with 240mL of room temperature water
Drug: zonisamide
100mg
B: Active Comparator
One 100mg capsule of reference product with 240mL room temperature water
Drug: zonisamide
100mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 heights 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 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

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Recalls, Market Withdrawals and Safety Alerts  This link exits the ClinicalTrials.gov site
Daily Med - Posting of Recently Submitted Labeling to the FDA  This link exits the ClinicalTrials.gov site
URL Pharma Generic Division  This link exits the ClinicalTrials.gov site

Responsible Party: Mutual Pharmaceutical Company, Inc. ( Kristin Arnold, Vice President R&D )
Study ID Numbers: R04-1376
Study First Received: May 24, 2008
Last Updated: May 24, 2008
ClinicalTrials.gov Identifier: NCT00685139  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Zonisamide

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Agents
Protective Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009