Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR - Full Text View

Purpose

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

Condition	Intervention	Phase
Epilepsy	Drug: Lamotrigine	Phase 1


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

Drug Information available for: Lamotrigine

U.S. FDA Resources

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 ]
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 ]


Enrollment:	180
Actual Study Start Date:	February 6, 2007
Study Completion Date:	April 27, 2007
Primary Completion Date:	April 27, 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


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

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: NCT00412191

Locations


Germany
GSK Investigational Site
Berlin, Germany, 14050

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

Results for study LAM105379 can be found on the GSK Clinical Study Register. This link exits the ClinicalTrials.gov site

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

Publications:

This study has not been published in the scientific literature.

Study Data/Documents: Statistical Analysis Plan This link exits the ClinicalTrials.gov site