A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

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
    

Intervention name(s): Lamotrigine; Lamictal
Intervention type(s): Drug; Drug
Intervention description(s): Lamotrigine, 100 mg Tablets, manufactured by Pharmtechnology LLC, Belarus; Lamictal®, 100 mg Tablets, marketed by GlaxoSmithKline Trading CJSC, Russia
Other intervention name(s): the test product; the reference product
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Bioequivalence; Lamotrigine