Expired Study
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Morgantown, West Virginia 26505


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.


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.


Study is Available At:


Original ID:

ZONI-0374


NCT ID:

NCT00650052


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Single-Dose Fasting In Vivo Bioequivalence Study of Zonisamide Capsules (100 mg; Mylan) to Zonegran® Capsules (100 mg; Elan) in Healthy Volunteers


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mylan Pharmaceuticals


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

107


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dorian Williams, M.D.
Principal Investigator
Kendle International Inc.

Study Dates

Start Date:November 2003
Completion Date:December 2003
Completion Type:Actual
Primary Completion Date:December 2003
Primary Completion Type:Actual
Verification Date:March 2008
Last Changed Date:March 31, 2008
First Received Date:March 30, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bioequivalence
Time Frame:within 30 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Zonisamide Capsules 100 mg
Description:100mg, single dose fasting
Arm Name:1
Intervention Type:Drug
Name:Zonegran® Capsules 100 mg
Description:100mg, single dose fasting
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Zonegran® Capsules 100 mg
Study Arm Type:Experimental
Arm Name:1
Description:Zonisamide Capsules 100 mg

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Mylan Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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