Last updated: 11/04/2018 08:47:25

Study to compare two formulations of lamotrigine in healthy subjects

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GSK study ID
LBI108614
See study documents
Clinicaltrials.gov ID
NCT00410371
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open-label, randomised, single-dose, parallel-group study to evaluate the pharmacokinetic characteristics, safety and tolerability of up to two formulations (with different taste masking approaches) of an orally disintegrating tablet (ODT) of lamotrigine at 25mg and 200mg versus the immediate release (IR) lamotrigine in healthy subjects
Trial description: This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Lamotrigine AUC(0-inf) and Cmax

Timeframe: Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours

Secondary outcomes:

tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points

Timeframe: throughout study

Interventions:
Drug: Lamotrigine
Drug: GI267119
Enrollment:
96
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Mental Disorders
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
December 2006 to January 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
19 - 55 years
Accepts healthy volunteers
Yes
  • Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive.
  • Female subjects of childbearing potential will not be eligible to participate if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
  • Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at Screening and pre-dose to the study) or lactating.
Inclusion and exclusion criteria
Inclusion criteria:
  • Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive.
Exclusion criteria:
  • Female subjects of childbearing potential will not be eligible to participate if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
  • Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at Screening and pre-dose to the study) or lactating.
  • Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD).
  • Female subjects using hormonal replacement therapy.
  • History of regular alcohol consumption
  • Current smokers of 10 or more cigarettes per day

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68502
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-25-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
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