Lamotrigine Bioequivalence

Exclusion Criteria

• •Subject is currently participating or has participated within the last 2 months in any trial of an investigational drug or experimental device.
• •Subject has a history of status epilepticus within the 12 month period prior to Visit 1.
• •Subject has any medical condition, which in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in the trial.
• •Subject has any psychiatric condition, which in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in this trial or confound the interpretation of the trial data.
• •Subject has known hypersensitivity to lamotrigine.
• •Subject has a medical condition that impacts drug absorption (e.g. gastric bypass surgery), including routine use (i.e. daily or weekly) use of acid blockers, antacids, anti-diarrhea, stimulants, appetite suppressants, or anti nausea medication or other drugs that modulate GI function.
• •Subject has any history of alcohol or drug abuse within the previous two years.
• •Subject has acute or subacutely progressive CNS disease.
• •Subject has moderate or severe liver impairment as assessed by alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ≥5 times the upper limit of normal (ULN).
• •Subject has moderate or severe renal impairment as assessed by creatinine clearance lower than 50mL/min, using the Cockcroft-Gault formula.
• •Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: condom with spermicide, diaphragm with spermicide, IUD without progesterone, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
• •Female subject is pregnant or nursing.
• •Female subject is using hormonal contraceptive precautions including progesterone-coated IUD.
• •Subjects is using hormonal replacement therapy.
• •Subject is unwilling or unable to maintain their approximate daily smoking use during the study.
• •Subject is using rifampin or other non-AED that strongly modulates lamotrigine levels.
• •In addition to lamotrigine and/or vagus nerve stimulation and/or intermittent benzodiazepine use (e.g. lorazepam, diazepam, clonazepam), subject is taking more than two concomitant AEDs.
• •Subject is not willing or able to be adherent to study protocol (e.g. dosing of lamotrigine and any interacting comedication).