This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00412191
First received: December 14, 2006
Last updated: August 3, 2017
Last verified: August 2017
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date: February 6, 2007
Study Completion Date: April 27, 2007
Primary Completion Date: April 27, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects in treatment regimen A
Subjects in treatment regimen A will receive 100 and 200 mg lamotrigine XR in fasting condition.
Drug: Lamotrigine
In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.
Experimental: Subjects in treatment regimen B
Subjects in treatment regimen B will receive 100 mg lamotrigine XR in fasting condition.
Drug: Lamotrigine
In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.
Experimental: Subjects in treatment regimen C
Subjects in treatment regimen C will receive 100 mg lamotrigine XR in fed condition.
Drug: Lamotrigine
In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412191

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

Additional Information:
Publications:
This study has not been published in the scientific literature.

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00412191     History of Changes
Other Study ID Numbers: LAM105379
Study First Received: December 14, 2006
Last Updated: August 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
healthy volunteers
bioequivalence
food effects

Additional relevant MeSH terms:
Lamotrigine
Anticonvulsants
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

ClinicalTrials.gov processed this record on September 21, 2017