MedTrace Logo

A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects

NCT02821338 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-05-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy

Interventions

DRUG

Lamotrigine Extended Release

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

Sponsors & Collaborators

  • Vince & Associates Clinical Research, Inc.

    collaborator OTHER

  • Algorithme Pharma Inc

    collaborator INDUSTRY

  • Food and Drug Administration (FDA)

    lead FED

Principal Investigators

  • Bradley Vince, D.O. · Vince and Associates Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-09-30
Completion
2017-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02821338 on ClinicalTrials.gov