Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Epilepsy

Treatments: Drug: Lamotrigine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412191

LAM105379

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

• Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria from at least the commencement of their last normal period prior to the first dose of study medication; and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 5 half lives of the study medication, whichever is the longest.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Subjects in treatment regimen A

Experimental group

Description:

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

Treatment:

Drug: Lamotrigine

Subjects in treatment regimen B

Experimental group

Description:

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

Treatment:

Drug: Lamotrigine

Subjects in treatment regimen C

Experimental group

Description:

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

Treatment:

Drug: Lamotrigine