Generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study.
Epilepsia（2023）
Abstract
The generic lamotrigine ER tablet product demonstrates BE to the brand product in a fully replicated BE study design with healthy subjects, supporting the adequacy of the two-way crossover study design to demonstrate BE and generic-brand substitution of lamotrigine ER products.
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Key words
bioequivalence,extended-release formulation,pharmacokinetics,replicated study,within-subject variability
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