Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

Study Description

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Brief Summary:

This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers

Condition or disease	Intervention/treatment	Phase
Epilepsy	Drug: Lamotrigine	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	180 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Pivotal Single-dose Randomised, Parallel-group, Open-label Study to Demonstrate Bioequivalence of 300mg Lamotrigine XR Relative to 100mg + 200mg Lamotrigine XR and to Demonstrate Lack of Food Effect on 300mg Lamotrigine XR in Healthy Male and Female Volunteers
Actual Study Start Date :	February 6, 2007
Actual Primary Completion Date :	April 27, 2007
Actual Study Completion Date :	April 27, 2007

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Subjects in treatment regimen A; Subjects in treatment regimen A will receive 100 and 200 mg lamotrigine XR in fasting condition.	Drug: Lamotrigine; In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.
Experimental: Subjects in treatment regimen B; Subjects in treatment regimen B will receive 100 mg lamotrigine XR in fasting condition.	Drug: Lamotrigine; In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.
Experimental: Subjects in treatment regimen C; Subjects in treatment regimen C will receive 100 mg lamotrigine XR in fed condition.	Drug: Lamotrigine; In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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 ]
2. safety and tolerability based on physical exam, adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate measure [ Time Frame: at Screening, Day -1, Day 1, Day 2 and follow up 7-14 days after dosing ]

Eligibility Criteria

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Ages Eligible for Study:	18 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 - 29.9 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.

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 hormonal replacement therapy.
• Subjects who received lamotrigine in a previous study (subjects who received placebo will be allowed).
• Current smokers of 10 or more cigarettes per day.

Contacts and Locations

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Locations

Germany
GSK Investigational Site
Berlin, Germany, 14050

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Results for study LAM105379 can be found on the GSK Clinical Study Register. 

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Statistical Analysis Plan 

Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: LAM105379
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

This study has not been published in the scientific literature.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00412191 History of Changes
Other Study ID Numbers:	LAM105379
First Posted:	December 15, 2006
Last Update Posted:	August 7, 2017
Last Verified:	August 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:

healthy volunteers; bioequivalence; food effects

Additional relevant MeSH terms:

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