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Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR
This study has been completed.
First Received: December 14, 2006   Last Updated: October 9, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00412191
  Purpose

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


Condition Intervention Phase
Epilepsy
Drug: Lamotrigine
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Bio-equivalence Study
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
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412191

Locations
Germany
GSK Investigational Site
Berlin, Germany, D-14050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: LAM105379
Study First Received: December 14, 2006
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00412191     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices;   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
bioequivalence
food effects
healthy volunteers

Study placed in the following topic categories:
Calcium, Dietary
Epilepsy
Lamotrigine
Calcium Channel Blockers
Central Nervous System Diseases
Cardiovascular Agents
Healthy
Brain Diseases
Anticonvulsants

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Central Nervous System Diseases
Calcium Channel Blockers
Cardiovascular Agents
Brain Diseases
Pharmacologic Actions
Membrane Transport Modulators
Epilepsy
Therapeutic Uses
Lamotrigine
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 11, 2009