A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects
Status:
Completed
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Food and Drug Administration (FDA)
Collaborators:
Algorithme Pharma Inc Vince & Associates Clinical Research, Inc.