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

NCT00649714 | Completed Phase 1

• 1 other identifier: ZONI-0375
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  within 30 days

Study Arms (2)

1

EXPERIMENTAL

Zonisamide Capsules 100 mg

Drug: Zonisamide Capsules 100 mg

2

ACTIVE COMPARATOR

Zonegran® Capsules 100 mg

Drug: Zonegran® Capsules 100 mg

Interventions

Zonisamide Capsules 100 mg DRUG

100mg, single dose fed

1

Zonegran® Capsules 100 mg DRUG

100mg, single dose fed

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years and older.
• Sex: Male.
• 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).
• 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.

You may not qualify if:

• Institutionalized subjects will not be used.
• Social Habits:
• Use of any tobacco products within 1 year of the start of the study.
• Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
• Ingestion of any vitamins or herbal products within the 7 days prior to the initial dose of the study medication.
• Any recent, significant change in dietary or exercise habits.
• A positive test for any drug included in the urine drug screen.
• History of drug and/or alcohol abuse.
• Medications:
• Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
• Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
• Diseases:
• History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
• Acute illness at the time of either the pre-study medical evaluation or dosing.
• A positive HIV, hepatitis B, or hepatitis C test.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Location

Related Links

• 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

MeSH Terms

Interventions

Zonisamide

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dorian Williams, M.D.

  Kendle International Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 1, 2008
• Study Start: December 1, 2003
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

US (1)