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Generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study.

Lanyan FangZhichuan LiMinori KinjoSara LomonacoNan ZhengWenlei JiangLiang Zhao
Published in: Epilepsia (2022)
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.
Keyphrases
  • open label
  • estrogen receptor
  • endoplasmic reticulum
  • double blind
  • breast cancer cells
  • placebo controlled
  • emergency department
  • randomized controlled trial