This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Lamotrigine Extended Release tablets 200mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL XR(containing Lamotrigine) Extended Release tablets 200mg of GlaxoSmithKline Research Triangle Park, NC in healthy, adult, human subjects under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Bioserve Clinical Research Private Limited
Bālānagar, Hyderabad, India
Area under curve(AUC)
Time frame: Blood samples were withdrawn at predose (0.00) and 2.00, 4.00, 6.00, 8.00, 9.00, 10.00, 12.00, 14.00, 15.50, 17.00, 18.50, 20.00, 21.50, 23.00, 24.50, 26.00, 27.50, 29.00, 36.00, 48.00, 72.00, 96.00, 120.00, 144.00 and 168.00 hours post-dose.
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