CI

At a glance

ClinicalIndex Comparison Record
Phase 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.

Search/NCT00834561
NCT00834561Phase 1Completed
CompareCT.gov

Randomized, Two-Way Crossover, Single-Dose, Fasting Bioequivalence Study of Lamotrigine 1 x 200 mg Tablet

Teva Pharmaceuticals USA·interventional·Posted Feb 3, 2009·Updated Aug 19, 2024

In Brief

A Phase 1 clinical trial evaluating Lamotrigine and Lamictal® for Healthy. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
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