Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      To evaluate and compare the bioavailability and therefore to assess the bioequivalence of two
      different formulations of lamotrigine after a single oral dose administration under fasting
      conditions.

      The secondary objective is to monitor the safety of the subjects.
    

Detailed description: 
      Study Design:

      Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover
      design

      Subjects:

      Twenty-two (22) subjects will be included in the study.

      Main Inclusion Criteria:

      Male and female volunteers, non- or ex-smokers, of at least 18 years of age to 54 years of
      age, inclusively, with a body mass index (BMI) within 22.00 to 30.00 kg/m2, inclusively, with
      a minimum body weight of 60 kg, will be selected according to the inclusion and exclusion
      criteria.

      Blood Sampling:

      In each study period, 23 blood samples will be collected. The first blood sample will be
      collected prior to drug administration while the others will be collected up to 192 hours
      after the drug administration.

      Wash-out:

      The drug administrations will be separated by at least 28 calendar days.

      Tests during study:

      An alcohol breath test will be performed before each period of the study. Screening for drugs
      of abuse will be performed before each period of the study. A C-SSRS questionnaire will be
      performed prior to each study period, as well as prior to discharge for each period of the
      study.

      For female subjects, a serum pregnancy test will be performed before each period of the
      study.

      Vital signs will be measured prior to and approximately 2, 4, 8, 10, 12, 24, 36 and 48 hours
      following each drug administration.

      Neurological function tests will be performed approximately 30 hours after each drug
      administration.

      For safety reasons, hematology tests will be performed before the 2nd period of the study.

      Post study Tests:

      Hematology, general biochemistry (including a serum pregnancy test for female subjects), and
      urinalysis tests will be repeated along with the collection of the last blood sample of the
      study.

      A complete physical examination (including vital signs) will also be performed.

      Bioanalysis: Lamotrigine plasma concentrations will be measured by a validated bioanalytical
      method.
    

Intervention name(s): Lamotrigine ER tablet 50mg
Intervention type(s): Drug
Intervention description(s): In each study period, a single 50 mg dose of lamotrigine will be administered orally with about 240 mL of water at ambient temperature, in the morning, while subjects are seated, following a 10-hour overnight fast.
Other intervention name(s): Reference- Lamictal® XRTM (Lamotrigine) ER tablet 50mg
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design
Masking: None (Open Label)
Primary purpose: Other