Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition

NCT01513681 | Completed Phase 1

• 1 other identifier: AAI-US-136
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Bioequivalence; Lamotrigine; crossover

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lamotrigine Tablets 200 mg

EXPERIMENTAL

Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited

Drug: Lamotrigine; Drug: Lamictal®

Lamictal® 200 mg Tablets

ACTIVE COMPARATOR

Lamictal® 200 mg Tablets of GlaxoSmithKline Inc

Drug: Lamotrigine; Drug: Lamictal®

Interventions

Lamotrigine DRUG

Lamotrigine Tablets 200 mg

Also known as: Lamictal® 200 mg

Lamictal® 200 mg Tablets; Lamotrigine Tablets 200 mg

Lamictal® DRUG

Lamictal® 200 mg Tablets

Lamictal® 200 mg Tablets; Lamotrigine Tablets 200 mg

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females at least 18 years of age inclusive
• Informed of the nature of the study and given written informed consent
• 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.

You may not qualify if:

• Hypersensitivity to Lamotrigine (Lamictal®) or similar compounds or any history of seizures or clinically significant neurological conditions.
• Any history of a clinical condition which might affect drug absorption, metabolism or excretion
• Recent history of mental illness, drug addition,drug abuse or alcoholism
• Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood.
• Received an investigational drug within the 4 weeks prior to study dosing.
• 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.
• Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing.
• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

AAI Clinic

Quadrangle Drive, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Lamotrigine

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dr. Ralph Scallion, MD

  AAI Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 20, 2012
• Study Start: November 1, 2002
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: January 20, 2012

Record last verified: 2002-10

Locations

US (1)