At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 34 enrolled
Drug / intervention
Zonisamide 100 mg Capsule +1 moredrug
Likely dose
Zonisamide 100 mg Capsulefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Relative Bioavailability Study of 100 mg Zonisamide Capsules Under Non-Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Zonisamide 100 mg Capsule and Zonisamide (Zonegran®) 100 mg Capsule for Healthy. Completed, enrolled 34 participants across 1 site.
Detailed Summary
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 formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2005
Primary CompletionMar 2005
First PostedMay 2008
TodayJul 2026
First PostedMay 30, 2008
Enrollment StartJan 1, 2005
Primary CompletionMar 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 18.1 years ago
Interventions
Zonisamide 100 mg Capsuledrug
100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.
Zonisamide (Zonegran®) 100 mg Capsuledrug
100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.