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

This is a single center, randomized, open-label, single dose, two treatment, four-period,
two-sequence, fully replicated crossover design in the fed state.

The study will include two treatments:

- Treatment-A: One dose of Lamotrigine extended-release tablet (Test) administered in the
morning after a 10-hour overnight fast and 30 minutes after the start of a high-fat,
high-calorie breakfast.

- Treatment-B: One dose of Lamictal XR extended-release tablet (Reference) administered in
the morning after a 10 hour overnight fast and 30 minutes after the start of a high-fat,
high-calorie breakfast.

A total of 30 healthy subjects will be dosed to ensure that at least 24 subjects will
complete the 4-period replicate design. For each treatment period, subjects will be confined
from the day prior to dosing until approximately 48 hours post-dose. Subjects will return to
the clinical site for the remaining blood samples. There will be a minimum 14-day washout
between doses.

Subject participation from the Screening Visit to the Follow-Up Visit will be approximately
71 days.

Inclusion Criteria:

1. Healthy male or female subjects ≥18 to ≤50 years of age

2. Subject is willing and able to provide informed consent

3. Body mass index (BMI) greater than or equal to 18.00 kg/m2 and below 30.00 kg/m2 at
screening

4. Body weight greater than or equal to 49 kg at screening

5. Subject is a non-smoker and has not used any nicotine containing products within 6
months prior to screening

6. 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

7. Subjects who are willing and able to comply with the visit schedule, laboratory tests,
pharmacokinetic sampling schedule and other study procedures

8. Subjects who are willing and able to maintain their eligibility throughout the study.

9. 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.

10. 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

11. 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:

1. Females who are pregnant or are breastfeeding

2. Females who are using any estrogen-containing hormonal contraceptives

3. 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

4. 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

5. 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

6. History of regular alcohol consumption exceeding 7 drinks per week for females and 14
drinks per week for males within 6 months of screening

7. Has current or recent history (within the past year) of alcohol or drug abuse or
dependence

8. Any clinically significant illness in the previous 30 days prior to screening

9. Use of any enzyme-modifying drugs, including strong inhibitors of CYP enzymes (such as
cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole,
ketoconazole, diltiazem, and HIV antivirals) and strong inducers of CYP enzymes (such
as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin, St John`s Wort)
in the previous 30 days prior to screening

10. Known presence of rare hereditary problems of galactose and /or lactose intolerance or
glucose-galactose malabsorption

11. Unusual dietary habits (e.g., vegan, Atkins), dietary restrictions, and/or food
allergies.

12. Any planned surgery from the screening visit until the end of the study

13. Positive urine screen for alcohol, cotinine and/or drugs of abuse at screening and at
each admission of each treatment period

14. Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg)
or Hepatitis C Antibody (HCVAb)

15. Albumin values less than 4 g/dL at screening

16. Triglyceride values greater than 200 mg/dL at screening

17. Treatment with any investigational drug 30 days prior to screening

18. Participation in other clinical studies within 30 days prior to screening

19. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days
prior to screening

20. Subject is unlikely to comply with the study protocol or, in the opinion of the
Investigator, would not be a suitable candidate for participation in the trial