Bioequivalence of two memantine tablet formulations in healthy Indonesian subjects

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 AUC_0-72h and C_max were calculated and used for bioequivalence evaluation after log-transformation.

Results: The point estimates and 90% confidence intervals for AUC_0-72h and CC_max 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.