Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg - Full Text View

Sponsor:	Mylan Pharmaceuticals
Information provided by:	Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00650052

Purpose

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 fasting conditions.

Condition	Intervention	Phase
Healthy	Drug: Zonisamide Capsules 100 mg Drug: Zonegran® Capsules 100 mg	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Single-Dose Fasting In Vivo Bioequivalence Study of Zonisamide Capsules (100 mg; Mylan) to Zonegran® Capsules (100 mg; Elan) in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Zonisamide

U.S. FDA Resources

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:

Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

Enrollment:	107
Study Start Date:	November 2003
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Zonisamide Capsules 100 mg	Drug: Zonisamide Capsules 100 mg 100mg, single dose fasting
Active Comparator: 2 Zonegran® Capsules 100 mg	Drug: Zonegran® Capsules 100 mg 100mg, single dose fasting

Eligibility

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

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Institutionalized subjects will not be used.
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.
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.
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.
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.
Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
Allergy or hypersensitivity to zonisamide or any other sulfa drugs.
History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650052

Locations

United States, West Virginia
Kendle International Inc.
Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Mylan Pharmaceuticals

Investigators

Principal Investigator:

Dorian Williams, M.D.

Kendle International Inc.

More Information

Additional Information:

Mylan Pharmaceuticals Inc. - Clinical Trial Results This link exits the ClinicalTrials.gov site

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use This link exits the ClinicalTrials.gov site

Recalls, Market Withdrawals and Safety Alerts This link exits the ClinicalTrials.gov site

FDA Enforcement Report Index This link exits the ClinicalTrials.gov site

Medwatch, FDA Safety Information and Adverse Event Reporting Program This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Will Sullivan, Global Head of Product Risk and Safety Management, Mylan Inc.
ClinicalTrials.gov Identifier:	NCT00650052 History of Changes
Other Study ID Numbers:	ZONI-0374
Study First Received:	March 30, 2008
Last Updated:	March 31, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Zonisamide
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents

Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012