Fed Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg
Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Zonisamide Capsules 100 mg (Drug); Zonegran® Capsules 100 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals Official(s) and/or principal investigator(s): Dorian Williams, M.D., Principal Investigator, Affiliation: Kendle International Inc.
Summary
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.
Clinical Details
Official title: Single-Dose Food In Vivo Bioequivalence Study of Zonisamide Capsules (100 mg; Mylan) to Zonegran® Capsules (100 mg; Elan) in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Kendle International Inc., Morgantown, West Virginia 26505, United States
Additional Information
Mylan Pharmaceuticals Inc. - Clinical Trial Results Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use Recalls, Market Withdrawals and Safety Alerts FDA Enforcement Report Index Medwatch, FDA Safety Information and Adverse Event Reporting Program
Starting date: December 2003
Last updated: March 31, 2008
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