Trial intelligence / Profile preview

Bioequivalence of Lamotrigine ER vs Lamictal XR in Healthy Subjects (Fed)

NCT02821338Phase 1Completed

Sponsor
Food and Drug Administration
Start
Jun 2016
Primary completion
Sep 2016
Modality
Small Molecules
Countries
1
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Overview

Phase 1, randomised, open-label trial of lamotrigine in epilepsy and bipolar disorder (BD) (2 arms), sponsored by Food and Drug Administration. Primary endpoints: Area Under the Lamotrigine Concentration vs. Time Curve From Sample Time Point 0 Hour to Sample Time Point 144 Hour, Area Under the Concentration-Time Curve From Time Zero to Infinity at 144 hours and 1 more. Started Jun 2016; status: completed.

02

Drugs

lamotrigine
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Conditions

epilepsybipolar disorder (BD)

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