Bioequivalence and Food Effect of 250mg of Lamotrigine XR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00605371
First received: January 18, 2008
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers


Condition Intervention Phase
Epilepsy
Bipolar Disorder
Drug: Lamotrigine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pivotal Single-dose, Randomised, Parallel-group, Open-label Study to Demonstrate Bioequivalence of 250mg Lamotrigine XR Relative to 200mg + 50mg Lamotrigine XR and to Demonstrate Lack of Food Effect on 250mg 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 ]
  • Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate
  • Serum lamotrigine AUC (0-t), tmax and t1/2

Estimated Enrollment: 226
Study Start Date: January 2008
Study Completion Date: March 2008
Intervention Details:
    Drug: Lamotrigine
    Other Name: Lamotrigine
  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects aged from 19 to 55 years, inclusive.
  • Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 - 32 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
  • Female subjects of non-child bearing potential will be eligible to participate if they meet the following criteria:

    • Post-menopausal females defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However if indicated this should be confirmed by oestradiol and FSH levels consistent with menopause (according to local laboratory ranges).
    • Pre-menopausal females with a documented (medical report verification) hysterectomy and/or bilateral oophorectomy, the latter only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    • Female subjects of child bearing potential will be eligible to participate if they comply with the contraception requirements.
  • A negative pre-study Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, and HIV antibody result at screening.
  • A negative pre-study urine drug screen.
  • A negative screen for alcohol (urine, blood or breath test).
  • Signed and dated written informed consent prior to admission to the study.

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 oestrogen-containing hormone replacement therapy.
  • Subjects who have received lamotrigine previously (subjects who received placebo in a previous study will be allowed)
  • History or evidence of drug or alcohol abuse within 12 months of study start.
  • QTc >450msec for women and QTc >430 msec for men on the screening 12-lead ECG.
  • Current smokers of 10 or more cigarettes per day.
  • History of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men within 6 months of screening. One drink is equivalent to 12 g alcohol = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
  • Has received prescribed or non-prescribed medication (including vitamins and herbal remedies) within 14 days prior to the dosing day, which in the opinion of the Principal/Co-Investigator, may interfere with the study procedures or compromise safety.
  • History of gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • History of clinically relevant skin rashes that, in the opinion of the investigator, might interfere with the conduct of the study.
  • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
  • History of allergic, anaphylactic, hypersensitivity or idiosyncratic reaction(s) to lamotrigine or drugs of a similar type.
  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: NCT00605371

Locations
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00605371     History of Changes
Other Study ID Numbers: LEP111102
Study First Received: January 18, 2008
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Healthy volunteers
Bioequivalence
Food Effects

Additional relevant MeSH terms:
Bipolar Disorder
Epilepsy
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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 July 22, 2014