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Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: December 14, 2006
Last updated: May 31, 2012
Last verified: March 2011
This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers

Condition Intervention Phase
Drug: Lamotrigine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • pharmacokinetics ie Serum lamotrigine Cmax and AUC(0-inf) [ Time Frame: taken pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours following dosing ]

Secondary Outcome Measures:
  • PK (AUC (0-t), tmax and t1/2 ) [ Time Frame: taken pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours following dosing ]
  • safety and tolerability based on physical exam, adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate measure [ Time Frame: at Screening, Day -1, Day 1, Day 2 and follow up 7-14 days after dosing ]

Enrollment: 180
Study Start Date: February 2007

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00412191

GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00412191     History of Changes
Other Study ID Numbers: LAM105379 
Study First Received: December 14, 2006
Last Updated: May 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
healthy volunteers
food effects

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers processed this record on September 28, 2016