Bioequivalence and Food Effect of 250mg of Lamotrigine XR

NCT ID: NCT00605371

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-15
• Study Completion Date: 2008-03-06

Brief Summary

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

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects receiving regimen A

Eligible subjects will receive regimen A containing lamotrigine extended release tablet of 200 milligrams plus 50 milligrams in fasted state

Group Type: EXPERIMENTAL

Lamotrigine tablet

Intervention Type: DRUG

Lamotrigine extended release single dose tablet will be available with dosing strengths of 200 milligrams and 50 milligrams intended to be administered orally in fasted state. It will be a round standard convex shape tablet.

Subjects receiving regimen B

Eligible subjects will receive regimen B containing lamotrigine extended release caplet of 250 milligrams in fasted state.

Group Type: EXPERIMENTAL

Lamotrigine caplet

Intervention Type: DRUG

Lamotrigine extended release single dose caplet will be available with dosing strength of 200 milligrams and 50 milligrams intended to be administered orally in fasted and fed state.

Subjects receiving regimen C

Eligible subjects will receive regimen C containing lamotrigine extended release caplet of 250 milligrams in fed state.

Group Type: EXPERIMENTAL

Lamotrigine caplet

Intervention Type: DRUG

Lamotrigine extended release single dose caplet will be available with dosing strength of 200 milligrams and 50 milligrams intended to be administered orally in fasted and fed state.

Interventions

Lamotrigine tablet

Lamotrigine extended release single dose tablet will be available with dosing strengths of 200 milligrams and 50 milligrams intended to be administered orally in fasted state. It will be a round standard convex shape tablet.

Intervention Type: DRUG

Lamotrigine caplet

Lamotrigine extended release single dose caplet will be available with dosing strength of 200 milligrams and 50 milligrams intended to be administered orally in fasted and fed state.

Intervention Type: DRUG

Eligibility 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.

• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tacoma, Washington, United States

Countries

United States

References

This study has not been published in the scientific literature.

Reference Type: BACKGROUND

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

LEP111102

Identifier Type: -

Identifier Source: org_study_id