Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lamotrigine; Drug: Lamictal®

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lamotrigine Tablets 200 mg; Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited	Drug: Lamotrigine; Lamotrigine Tablets 200 mg; Other Names: Lamictal® 200 mg; Drug: Lamictal®; Lamictal® 200 mg Tablets
Active Comparator: Lamictal® 200 mg Tablets; Lamictal® 200 mg Tablets of GlaxoSmithKline Inc	Drug: Lamotrigine; Lamotrigine Tablets 200 mg; Other Names: Lamictal® 200 mg; Drug: Lamictal®; Lamictal® 200 mg Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under curve (AUC)	Pre-dose 0.25, 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 hours

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Dr. Ralph Scallion, MD, AAI Clinic

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): November 1, 2002
• Study Completion (Actual): November 1, 2002

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 20, 2012

Study Record Updates

• Last Update Posted (Estimate): January 20, 2012
• Last Update Submitted That Met QC Criteria: January 17, 2012
• Last Verified: October 1, 2002

More Information

Terms related to this study

• Keywords: Bioequivalence; Lamotrigine; crossover
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Lamotrigine
• Other Study ID Numbers: AAI-US-136