CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Lamotrigine Extended Releasedrug
Likely dose
Not stated in 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/NCT02821338
NCT02821338Phase 1Completed
CompareCT.gov

A Randomized, 2-Sequence, 2-Treatment, 4-Period, Open-Label, Single Dose, Fully Replicated Comparative Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects Under Fed Conditions

Food and Drug Administration (FDA)·interventional·Posted Jul 1, 2016·Updated May 1, 2020

In Brief

A Phase 1 clinical trial evaluating Lamotrigine Extended Release for Healthy. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The objective of this study is to determine bioequivalence between two different formulations of lamotrigine extended release tablets (one reference product and one generic product) in a healthy adult population, following a single oral dose under fed conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsVince & Associates Clinical Research, Inc., Algorithme Pharma Inc

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 1, 2016
Enrollment StartJun 1, 2016
Primary CompletionSep 1, 2016
Study CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.0 years ago

Interventions

Lamotrigine Extended Releasedrug

Lamotrigine Extended Release (generic) and Lamictal XR (brand).