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Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00410371
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Mental Disorders Drug: Lamotrigine Drug: GI267119 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 28, 2006
Primary Completion Date : January 25, 2007
Study Completion Date : January 25, 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: GI267119
25 mg ODT tablet strength
Drug: Lamotrigine
Lamotrigine
Drug: GI267119
25 mg ODT


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points [ Time Frame: throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: LBI108614
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: LBI108614
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: LBI108614
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: LBI108614
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: LBI108614
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: LBI108614
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: LBI108614
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00410371     History of Changes
Other Study ID Numbers: LBI108614
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 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:
tolerability
safety
Pharmacokinetic characteristics

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
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