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Fed Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00649714
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008

March 30, 2008
March 31, 2008
December 2003
January 2004   (final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00649714 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Fed Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg
Single-Dose Food In Vivo Bioequivalence Study of Zonisamide Capsules (100 mg; Mylan) to Zonegran® Capsules (100 mg; Elan) in Healthy Volunteers

The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Healthy
  • Drug: Zonisamide Capsules 100 mg
    100mg, single dose fed
  • Drug: Zonegran® Capsules 100 mg
    100mg, single dose fed
  • Experimental: 1
    Zonisamide Capsules 100 mg
    Intervention: Drug: Zonisamide Capsules 100 mg
  • Active Comparator: 2
    Zonegran® Capsules 100 mg
    Intervention: Drug: Zonegran® Capsules 100 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
January 2004
January 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age: 18 years and older.
  2. Sex: Male.
  3. Weight: At least 60 kg (132 lbs) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
  4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Exclusion Criteria:

  1. Institutionalized subjects will not be used.
  2. Social Habits:

    1. Use of any tobacco products within 1 year of the start of the study.
    2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
    3. Ingestion of any vitamins or herbal products within the 7 days prior to the initial dose of the study medication.
    4. Any recent, significant change in dietary or exercise habits.
    5. A positive test for any drug included in the urine drug screen.
    6. History of drug and/or alcohol abuse.
  3. Medications:

    1. Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
    2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
  4. Diseases:

    1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
    2. Acute illness at the time of either the pre-study medical evaluation or dosing.
    3. A positive HIV, hepatitis B, or hepatitis C test.
  5. Abnormal and clinically significant laboratory test results:

    1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
    2. Abnormal and clinically relevant ECG tracing.
  6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
  7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
  8. Allergy or hypersensitivity to zonisamide or any other sulfa drugs.
  9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
  10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00649714
ZONI-0375
Not Provided
Will Sullivan, Global Head of Product Risk and Safety Management, Mylan, Inc.
Mylan Pharmaceuticals
Not Provided
Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
Mylan Pharmaceuticals
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP