Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-28

Study Completion Date

2007-01-25

Brief Summary

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This study intends to compare the pharmacokinetic characteristics, 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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GI267119

25 mg ODT tablet strength

Group Type EXPERIMENTAL

Lamotrigine

Intervention Type DRUG

Lamotrigine

GI267119

Intervention Type DRUG

25 mg ODT

Interventions

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Lamotrigine

Intervention Type DRUG

GI267119

25 mg ODT

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 to 30 kg/m2 inclusive.

Exclusion Criteria

* Female subjects of childbearing potential will not be eligible to participate 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 (positive serum human chorionic gonadotrophin (hCG) test at Screening and pre-dose to the study) 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
* 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

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Study Documents

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