This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
209
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.
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.
GSK Investigational Site
Tacoma, Washington, United States
Pharmacokinetics ie Serum lamotrigine Cmax and AUC(0-inf)
Time frame: Pre-dose and 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 Post-dose
PK (AUC (0-t), tmax and t1/2 )
Time frame: Pre-dose and 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 Post-dose
Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate
Time frame: Up to day 21
Serum lamotrigine AUC (0-t), tmax and t1/2
Time frame: Pre-dose and 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 Post-dose
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