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

Research output: Contribution to journalArticle

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 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.

Original languageEnglish
Pages (from-to)478-482
Number of pages5
JournalInternational Journal of Clinical Pharmacology and Therapeutics
Volume57
Issue number9
DOIs
Publication statusPublished - 1 Jan 2019

Keywords

  • Amantadine HCl
  • Bioequivalence
  • LC-MS/MS
  • Memantine HCl
  • Pharmacokinetics

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