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Bioequivalence of two memantine tablet formulations in healthy Indonesian subjects
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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