Conditions: Healthy
Keywords: Bioequivalence Lamotrigine Extended Release Generic Pharmacokinetic
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: The treatments will be administered according to a randomly assigned pre-generated sequence involving the randomized, four-period, two sequence, fully replicate crossover design. Two study drugs involved are: Lamotrigine Extended Release (generic) and Lamictal XR (brand). arm 2: The treatments will be administered according to a randomly assigned pre-generated sequence involving the four-period, two sequence, fully replicate crossover design. Two study drugs involved are: Lamotrigine Extended Release (generic) and Lamictal XR (brand).

Interventions: intervention 1: Lamotrigine Extended Release
Intervention descriptions: intervention 1: Lamotrigine Extended Release (generic) and Lamictal XR (brand).

Protocol document: