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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-07

Study Completion Date

2007-06-19

Brief Summary

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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

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Detailed Description

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Conditions

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Mental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects in Treatment regimen F

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

Group Type EXPERIMENTAL

Lamotrigine ODT tablets

Intervention Type DRUG

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

Subjects in Treatment regimen C

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

Group Type EXPERIMENTAL

Lamotrigine ODT tablets

Intervention Type DRUG

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

Subjects in Treatment regimen D

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

Group Type EXPERIMENTAL

Lamotrigine IR tablets

Intervention Type DRUG

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

Subjects in Treatment regimen E

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

Group Type EXPERIMENTAL

Lamotrigine ODT tablets

Intervention Type DRUG

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

Interventions

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Lamotrigine IR tablets

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

Intervention Type DRUG

Lamotrigine ODT tablets

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

Intervention Type DRUG

Other Intervention Names

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Lamotrigine

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Dallas, Texas, United States

Site Status

Countries

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United States

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

Study Documents

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