Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-06

Study Completion Date

2007-04-27

Brief Summary

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This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers

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Detailed Description

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Conditions

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Epilepsy

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 A

Subjects in treatment regimen A will receive 100 and 200 mg lamotrigine XR in fasting condition.

Group Type EXPERIMENTAL

Lamotrigine

Intervention Type DRUG

In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.

Subjects in treatment regimen B

Subjects in treatment regimen B will receive 100 mg lamotrigine XR in fasting condition.

Group Type EXPERIMENTAL

Lamotrigine

Intervention Type DRUG

In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.

Subjects in treatment regimen C

Subjects in treatment regimen C will receive 100 mg lamotrigine XR in fed condition.

Group Type EXPERIMENTAL

Lamotrigine

Intervention Type DRUG

In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.

Interventions

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Lamotrigine

In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body weight \>50 kg (males) or \>45 kg (females) and BMI within the range 19 - 29.9 kg/m2 inclusive.
* Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.

* Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at screening) or lactating.
* Female subjects using hormonal contraceptive precautions including progesterone-coated IUD
* Female subjects using hormonal replacement therapy.
* Subjects who received lamotrigine in a previous study (subjects who received placebo will be allowed).
* Current smokers of 10 or more cigarettes per day.

Minimum Eligible Age

18 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

Berlin, , Germany

Site Status

Countries

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Germany

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

Study Documents

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