NCT03898011

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

Single-Dose Open-label Randomized Crossover, in Two Periods and in Two Sequences, Single-Center Comparative Bioequivalence Study of Two Formulations Lamotrigine, 100 mg Tablets (Pharmtechnology LLC, Republic of Belarus), and Lamictal®, 100 mg Tablets (GlaxoSmithKline Trading Closed Joint-Stock Company (CJSC), Russia), in Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Pharmtechnology LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

The objective of this study is to establish if two formulations of lamotrigine are bioequivalent. Also monitoring, registration and evaluation of adverse events that can be performed. The test formulation is Lamotrigine, Tablets 100 mg (Pharmtechnology LLC, Belarus). The reference formulation is Lamictal®, Tablets 100 mg (GlaxoSmithKlein Trading CJSC, Russia). 28 healthy adult volunteers of both genders, with age ranging from 18 to 45 years old, will be divided into two cohorts with equal number of subjects (14). Each participant in a cohort will receive single tablet (100 mg of lamotrigine) of the test or the reference products with 200 ml of water after an overnight fast of at least 10 hours. Participants will fast 4 hours after administration of the study drugs. Next meals will be after 6, 9 and 12 hours after administration of formulations. Standardized meals will be provided in each study period. Water will not be accessible to the participants 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period. In each period blood samples will be collected during 30 minutes before dosing and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.5, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00, 72.00, 96.00, 120.00 hours after dosing (total number: 23). The washout period will be 21 days. At the bio-analytical stage, a validated High Performance Liquid Chromatography with tandem Mass Spectrometry detection (HPLC/MS) method will be used to determine plasma concentrations of lamotrigine. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, Area Under the pharmacokinetic Curve from the beginning of the study till the time of the last measured concentration (AUC0-t) and 90% confidence interval will be constructed for the ratio of geometric means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for lamotrigine falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	Lamotrigine	Lamotrigine, 100 mg Tablets, manufactured by Pharmtechnology LLC, Belarus
DRUG	Lamictal	Lamictal®, 100 mg Tablets, marketed by GlaxoSmithKline Trading CJSC, Russia

Timeline

• Start date: 2019-03-23
• Primary completion: 2019-05-04
• Completion: 2019-05-04
• First posted: 2019-04-01
• Last updated: 2019-06-06

Locations

1 site across 1 country: Russia