At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Lamotrigine +1 moredrug
Likely dose
Lamotrigine 200 mgfrom 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 200 mg Tablets and Lamictal® 200 mg Tablets Administered as 1 x 200 mg Tablet in Healthy Subjects Under Fed Conditions
In Brief
A Phase 1 clinical trial evaluating Lamotrigine and Lamictal® 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 200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2002
Primary CompletionFeb 2002
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartJan 1, 2002
Primary CompletionFeb 1, 2002
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Lamotriginedrug
200 mg Tablet
Lamictal®drug
200 mg Tablet