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. 2019 Sep;57(9):478-482.
doi: 10.5414/CP203386.

Bioequivalence of two memantine tablet formulations in healthy Indonesian subjects

Yahdiana Harahap, Budi Prasaja, Monika Sandra, Tri Rahayu, Windy Lusthom, Anna Sofiana, Kristiyani Irawati, Yunia Trisari

Bioequivalence of two memantine tablet formulations in healthy Indonesian subjects

Yahdiana Harahap et al. Int J Clin Pharmacol Ther. 2019 Sep.

Abstract

Aim: To compare the bioequivalence of two 10-mg memantine tablet formulations.

Materials and methods: 19 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 5-week washout period was applied. Blood samples were collected up to 72 hours following drug administrations. Plasma memantine concentrations were determined by LC-MS/MS. The pharmacokinetic parameters AUC0-72h and Cmax were calculated and used for bioequivalence evaluation after log-transformation.

Results: The point estimates and 90% confidence intervals for AUC0-72h and CCmax for memantine were 100.72% (97.43 - 104.13%) and 101.46% (97.15 - 105.96%), respectively.

Conclusion: These results indicated that the two formulations of memantine were bioequivalent; therefore, they may be prescribed interchangeably.

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