Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions
Condition: Healthy
Intervention: Lamotrigine; Lamictal®
Intervention description: 200 mg Tablet; 200 mg Tablet
Intervention MeSH terms: Lamotrigine
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine
      (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria

          -  Subjects will be females and/or males, non-smokers, 18 years of age and older.

          -  Female Subjects will be post-menopausal or surgically sterilized.

          -  Post-menopausal status is defined as absence of menses for the past 12 months,

          -  Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at
             least 6 months ago.

        Exclusion Criteria

        Subjects to whom any of the following applies will be excluded from the study:

          -  Clinically significant illnesses within 4 weeks of the administration of study
             medication.

          -  Clinically significant surgery within 4 weeks prior to the administration of the study
             medication.

          -  Any clinically significant abnormality found during medical screening.

          -  Subjects with a history of renal, hepatic or cardiovascular disease, tuberculosis,
             epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.

          -  Any reason which, in the opinion of the medical subinvestigator, would prevent the
             subject from participating in the study.

          -  Abnormal laboratory tests judged clinically significant.

          -  Positive urine drug screen at screening.

          -  Positive testing for hepatitis B, hepatitis C or HIV at screening.

          -  ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood
             pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or
             over 90; or heart rate less than 50 bpm) at screening.

          -  Subjects with BMI ≥30.0.

          -  History of significant alcohol abuse within six months of the screening visit or any
             indication of the regular use of more than two units of alcohol per day (1 Unit = 150
             mL of wine or 360 mL of beer or 45 mL of alcohol 40%).

          -  History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana)
             within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine
             (PCP) and crack) within 1 year of the screening visit.

          -  Any food allergy, intolerance, restriction or special diet that, in the opinion of the
             medical subinvestigator, contraindicates the subject's participation in this study.

          -  History of allergic reactions to lamotrigine.

          -  Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of
             inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin;
             examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin,
             ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid, use
             of an investigational drug or participation on an investigation study within 30 days
             prior to the administration of the study medication.

          -  Use of prescription medication within 14 days prior to administration of study
             medication or over-the-counter products )including natural products, vitamins, garlic
             as a supplement) within 7 days prior to administration of study medication, except for
             topical products without systemic absorption.

          -  Subjects who have had a depot injection or an implant of any drug 3 months prior to
             administration of study medication.

          -  Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to
             administration of the study medication as follows:

          -  Less than 300 mL of whole blood within 30 days or

          -  300 mL to 500 mL of whole blood within 45 days or

          -  more than 500 mL of whole blood within 56 days.

          -  Positive alcohol breath test at screening.

          -  Subjects who have used tobacco in any form within the 90 days preceding study drug
             administration.

        Additional exclusion criteria for female subjects only:

          -  Breast feeding subjects.

          -  Positive urine pregnancy test at screening (performed on all females).