Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00410371
First received: December 11, 2006
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers


Condition Intervention Phase
Healthy Subjects
Mental Disorders
Drug: Lamotrigine
Drug: GI267119
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomised, Single-dose, Parallel-group Study to Compare the Pharmacokinetic Characteristics, Safety and Tolerability of Two Formulations of Lamotrigine in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Lamotrigine AUC(0-inf) and Cmax [ Time Frame: 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 Outcome Measures:
  • tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points [ Time Frame: throughout study ]

Enrollment: 96
Study Start Date: December 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GI267119
25 mg ODT tablet strength
Drug: Lamotrigine
Lamotrigine
Other Name: Lamotrigine
Drug: GI267119
25 mg ODT

  Eligibility

Ages Eligible for Study:   19 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410371

Locations
United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00410371     History of Changes
Other Study ID Numbers: LBI108614
Study First Received: December 11, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
tolerability
safety
Pharmacokinetic characteristics

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014