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Sponsored by: |
Mutual Pharmaceutical Company, Inc. |
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Information provided by: | Mutual Pharmaceutical Company, Inc. |
ClinicalTrials.gov Identifier: | NCT00685139 |
The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference Zonegran Capsules in healthy adult subjects under fasting conditions
Condition | Intervention | Phase |
---|---|---|
Therapeutic Equivalency |
Drug: zonisamide |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Investigator), Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of 100mg Zonisamide Capsules Under Fasting Conditions |
Enrollment: | 34 |
Study Start Date: | January 2005 |
Study Completion Date: | March 2005 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
One 100mg capsule with 240mL of room temperature water
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Drug: zonisamide
100mg
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B: Active Comparator
One 100mg capsule of reference product with 240mL room temperature water
|
Drug: zonisamide
100mg
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Mutual Pharmaceutical Company, Inc. ( Kristin Arnold, Vice President R&D ) |
Study ID Numbers: | R04-1376 |
Study First Received: | May 24, 2008 |
Last Updated: | May 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00685139 |
Health Authority: | United States: Institutional Review Board |
Zonisamide |
Antioxidants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Central Nervous System Agents Protective Agents Anticonvulsants Pharmacologic Actions |