NCT02821338

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Food and Drug Administration (FDA) · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single center, randomized, open-label, single dose, two treatment, four-period, two-sequence, fully replicated crossover design in the fed state. The study will include two treatments: * Treatment-A: One dose of Lamotrigine extended-release tablet (Test) administered in the morning after a 10-hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast. * Treatment-B: One dose of Lamictal XR extended-release tablet (Reference) administered in the morning after a 10 hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast. A total of 30 healthy subjects will be dosed to ensure that at least 24 subjects will complete the 4-period replicate design. For each treatment period, subjects will be confined from the day prior to dosing until approximately 48 hours post-dose. Subjects will return to the clinical site for the remaining blood samples. There will be a minimum 14-day washout between doses. Subject participation from the Screening Visit to the Follow-Up Visit will be approximately 71 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lamotrigine Extended Release	Lamotrigine Extended Release (generic) and Lamictal XR (brand).

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-09-01
• Completion: 2017-04-01
• First posted: 2016-07-01
• Last updated: 2020-05-01
• Results posted: 2020-05-01

Locations

1 site across 1 country: United States