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 Cmax 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 bio-equivalent; therefore, they may be prescribed interchangeably.
|Number of pages||5|
|Journal||International Journal of Clinical Pharmacology and Therapeutics|
|Publication status||Published - 1 Jan 2019|
- Amantadine HCl
- Memantine HCl