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CompletedNCT00412191Updated Aug 7, 2017

Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

A Phase 1 interventional study of Lamotrigine in Epilepsy, sponsored by GlaxoSmithKline. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-07.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Epilepsy

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Keywords

  • healthy volunteers
  • bioequivalence
  • food effects
03

In context

Epilepsy

1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 180 is above the median of 50 across 1,205 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    Subjects in treatment regimen A

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

    Drug: Lamotrigine

  • Experimental
    Subjects in treatment regimen B

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

    Drug: Lamotrigine

  • Experimental
    Subjects in treatment regimen C

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

    Drug: Lamotrigine

Interventions

  • DrugLamotrigine

    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.

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • GSK Investigational Site
    Berlin, 14050, Germany
08

References and documents

Publications

  • This study has not been published in the scientific literature.

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00412191
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Dec 15, 2006
Start date
Feb 6, 2007
Primary completion
Apr 27, 2007
Completion
Apr 27, 2007
Last update
Aug 7, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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