Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

An Open-label, Randomised, Single-dose, Parallel-group Study to Evaluate the Pharmacokinetic Characteristics, Safety and Tolerability of up to Two Formulations (With Different Taste Masking Approaches) of an Orally Disintegrating Tablet (ODT) of Lamotrigine at 25mg and 200mg Versus the Immediate Release (IR) Lamotrigine in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00410371

Enrollment

Registered

2006-12-12

Start date

2006-12-28

Completion date

2007-01-25

Last updated

2017-09-12

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

Conditions

Mental Disorders

Keywords

tolerability, safety, Pharmacokinetic characteristics

Brief summary

This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers

Interventions

DRUGLamotrigine

Lamotrigine

DRUGGI267119

25 mg ODT

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

* 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

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

Secondary

Measure	Time frame
tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points	throughout study

Countries

United States

Outcome results

None listed

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