At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Lamotrigine 25 mg Chewable Tablets +1 moredrug
Likely dose
Lamotrigine 25 mg Chewable Tabletsfrom 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.
Randomized, 2-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Dispersible Tablets and Lamictal® 25 mg Chewable Dispersible Tablets in Healthy Subjects Under Fed Conditions
In Brief
A Phase 1 clinical trial evaluating Lamotrigine 25 mg Chewable Tablets and Lamictal® 25 mg Chewable Tablets for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2002
Primary CompletionMar 2002
First PostedFeb 2009
TodayJul 2026
First PostedFeb 6, 2009
Enrollment StartFeb 1, 2002
Primary CompletionMar 1, 2002
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Lamotrigine 25 mg Chewable Tabletsdrug
2 x 25 mg, single-dose fed
Lamictal® 25 mg Chewable Tabletsdrug
2 x 25 mg, single-dose fed