Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers

NCT00449774 | Completed Phase 1

• 1 other identifier: LBI108617
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers

Conditions

Mental Disorders

Keywords

Food effect; Safety; Tolerability; Water effect; Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Lamotrigine AUC(0-inf) and Cmax. Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours

  Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours

Secondary Outcomes (1)

• Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above. Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate at various times during the study.

  Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above

Study Arms (4)

Subjects in Treatment regimen C

EXPERIMENTAL

Subjects in treatment regimen C will receive 200 milligram (mg) orally disintegrating tablets (ODT) of lamotrigine disintegrate in mouth without water in fasting condition.

Drug: Lamotrigine ODT tablets

Subjects in Treatment regimen D

EXPERIMENTAL

Subjects in treatment regimen D will receive 200 mg Immediate Release (IR) tablets of lamotrigine with water in fasting condition.

Drug: Lamotrigine IR tablets

Subjects in Treatment regimen E

EXPERIMENTAL

Subjects in treatment regimen E will receive 200 mg ODT disintegrate of lamotrigine in mouth without water in fed state.

Drug: Lamotrigine ODT tablets

Subjects in Treatment regimen F

EXPERIMENTAL

Subjects in treatment regimen F will receive 200 mg ODT of lamotrigine, that subjects will swallow with water in fasting condition.

Drug: Lamotrigine ODT tablets

Interventions

Lamotrigine IR tablets DRUG

Lamotrigine IR tablets will be available in dose strength of 200 mg.

Also known as: Lamotrigine

Subjects in Treatment regimen D

Lamotrigine ODT tablets DRUG

Lamotrigine ODT tablets will be available in dose strength of 200 mg.

Subjects in Treatment regimen C; Subjects in Treatment regimen E; Subjects in Treatment regimen F

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects aged 19 to 55 years inclusive
• BMI within the range 19 to 32 kg/m2 inclusive.

You may not qualify if:

• Female subjects of childbearing potential will not be eligible if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
• Female subject is pregnant or lactating.
• Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD).
• Female subjects using hormonal replacement therapy.
• History of regular alcohol consumption \> 7 drinks week for women and 14 drinks week for men
• Current smokers of 10 or more cigarettes per day

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Dallas, Texas, 75247, United States

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study LBI108617 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Mental Disorders

Interventions

Lamotrigine

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 19, 2007
• First Posted: March 21, 2007
• Study Start: May 7, 2007
• Primary Completion: June 19, 2007
• Study Completion: June 19, 2007
• Last Updated: August 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)