A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects

Inclusion Criteria

• Healthy male or female subjects ≥18 to ≤50 years of age
• Subject is willing and able to provide informed consent
• Body mass index (BMI) greater than or equal to 18.00 kg/m2 and below 30.00 kg/m2 at screening
• Body weight greater than or equal to 50 kg at screening
• Subject is a non-smoker and has not used any nicotine containing products within 6 months prior to screening
• Subjects who are considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results and screening ECG in the opinion of the Investigator
• Subjects who are willing and able to comply with the visit schedule, laboratory tests, pharmacokinetic sampling schedule and other study procedures
• Subjects who are willing and able to maintain their eligibility throughout the study.
• A female study subject must meet one of the following criteria:
• If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study, and for at least 30 days after the last dose of the study medication. An acceptable method of contraception includes one of the following:
• Abstinence from heterosexual intercourse
• Progestogen-containing hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
• Intrauterine device (without hormones)
• Condom with spermicide
• If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by FSH levels (post menopausal must be confirmed by the subject having a serum follicle stimulating hormone greater than 40mIU/ml at screening). Females of non-childbearing potential must present a proof of partial or total hysterectomy; if such proof is not available, the female will be considered to be of childbearing potential.
• A male study subject must agree to use one of the accepted contraceptive regimens during the study and for at least 90 days after the last dose of the study medication;
• Abstinence from heterosexual intercourse
• Female partner with hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
• Female partner with intrauterine device (with or without hormones)
• Female partner with condom with spermicide used by male study subject
• Female partner of non-childbearing potential
• Male sterilization with absence of sperm in the post vasectomy ejaculate
• A male study subject must agree not to donate sperm during the study and for at least 90 days after the last dose of the study medication

Exclusion Criteria

• Females who are pregnant or are breastfeeding
• Females who are using any estrogen-containing hormonal contraceptives
• History of known clinically significant drug allergies or reactions to lamotrigine, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs in the opinion of the Investigator
• Clinically significant history or evidence of gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, cardiovascular, hematologic, dermatologic, immunologic disease or any other condition known to interfere with the absorption, distribution, metabolism or distribution of drugs that in the opinion of the Investigator would jeopardize the safety of the subject or impact validity of study results
• Presence of observed abnormality (evidenced from physical examination, ECG, vital signs, or laboratory evaluation) that would be clinically significant in the opinion of the Investigator
• History of regular alcohol consumption exceeding 7 drinks per week for females and 14 drinks per week for males within 6 mont