Overview

A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions

Status:
Completed

Trial end date:
2019-05-04

Target enrollment:

Participant gender:

Summary

This is an open-labeled, randomized, crossover, two-period, single-center, comparative study, where each participant will be randomly assigned to the reference (Lamictal, 100 mg tablets) or the test (Lamotrigine, 100 mg tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent

Phase:

Phase 1

Details

Lead Sponsor:

Pharmtechnology LLC

Collaborator:

ClinPharmInvest, LLC

Treatments:

Anticonvulsants
Lamotrigine