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

An Open-label, Randomised, Single-dose, Parallel-group Study to Demonstrate Bioequivalence of Two Formulations and the Effect of Food and Water on One Formulation of Lamotrigine in Healthy Male and Female Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00449774

Enrollment

220

Registered

2007-03-21

Start date

2007-05-07

Completion date

2007-06-19

Last updated

2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders

Keywords

Food effect, Safety, Tolerability, Water effect, Bioequivalence

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

Interventions

DRUGLamotrigine IR tablets

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

DRUGLamotrigine ODT tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026