Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition

Condition(s) targeted: Healthy

Intervention: Lamotrigine (Drug); Lamictal® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Dr. Ralph Scallion, MD, Principal Investigator, Affiliation: AAI Clinic

This is an single dose,two-way, crossover, oral bioequivalence study.

Official title: Single Dose, Two-way, Crossover, Oral Bioequivalence Study of Lamotrigine Tablets 200 mg With Lamictal® Tablets 200 mg in Healthy, Volunteers Under Fed Condition.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area under curve (AUC)

Detailed description: The study was an single dose, two-way, crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fed condition. 20 subjects (14 male and 6 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.

Minimum age: 18 Years. Maximum age: 44 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Healthy males and females at least 18 years of age inclusive 2. Informed of the nature of the study and given written informed consent 3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs. Exclusion Criteria: 1. Hypersensitivity to Lamotrigine (Lamictal®) or similar compounds or any history of seizures or clinically significant neurological conditions. 2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion 3. Recent history of mental illness, drug addition,drug abuse or alcoholism 4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood. 5. Received an investigational drug within the 4 weeks prior to study dosing. 6. Currently taking any prescription medication, except oral contraceptives, within the

7 days prior to study dosing or over-the - counter medication within 3 days of study

dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutics indications as judged by the attending physician. 7. Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing. 8. If female, the subjects is lactating or has a positive pregnancy test screening and prior to each of the two treatments periods. Females of child bearing potential must use a medical acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods or contraception that may be used by the subject and/or her partner are; oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.

AAI Clinic, Quadrangle drive, North Carolina 27514, United States

Starting date: November 2002
Last updated: January 17, 2012