The purpose of this study is to determine the pharmacokinetics and bioequivalence of lamotrigine formulations after administration of single doses to non-smoking, healthy volunteers under fasted conditions.
A single-dose, two-way, bioequivalence study in up to 26 normal, non-smoking, healthy males and females will be utilized to evaluate the pharmacokinetics and bioequivalence of Lamotrigine chewable dispersible formulations under fasted conditions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Lamotrigine Tablets (chewable, dispersible), 25 mg
AAI Clinic
Chapel Hill, North Carolina, United States
Bioequivalence based on Cmax and AUC parameters
Time frame: 3 months
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