Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

Condition(s) targeted: Epilepsy

Intervention: Lamotrigine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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

Official title: A Pivotal Single-dose Randomised, Parallel-group, Open-label Study to Demonstrate Bioequivalence of 300mg Lamotrigine XR Relative to 100mg + 200mg Lamotrigine XR and to Demonstrate Lack of Food Effect on 300mg Lamotrigine XR in Healthy Male and Female Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: pharmacokinetics ie Serum lamotrigine Cmax and AUC(0-inf)

Secondary outcome:

PK (AUC (0-t), tmax and t1/2 )

safety and tolerability based on physical exam, adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate measure

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

GSK Investigational Site, Berlin 14050, Germany

Starting date: February 2007
Last updated: May 31, 2012