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

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

Department of Pharmacy

Research output: Contribution to journal › Article › peer-review

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 C_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 bio-equivalent; therefore, they may be prescribed interchangeably.

Original language	English
Pages (from-to)	478-482
Number of pages	5
Journal	International Journal of Clinical Pharmacology and Therapeutics
Volume	57
Issue number	9
DOIs	https://doi.org/10.5414/CP203386
Publication status	Published - 1 Jan 2019

Keywords

Amantadine HCl
Bioequivalence
LC-MS/MS
Memantine HCl
Pharmacokinetics

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title = "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 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.",

keywords = "Amantadine HCl, Bioequivalence, LC-MS/MS, Memantine HCl, Pharmacokinetics",

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

year = "2019",

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doi = "10.5414/CP203386",

language = "English",

volume = "57",

pages = "478--482",

journal = "International Journal of Clinical Pharmacology and Therapeutics",

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T1 - Bioequivalence of two memantine tablet formulations in healthy Indonesian subjects

AU - Harahap, Yahdiana

AU - Prasaja, Budi

AU - Sandra, Monika

AU - Rahayu, Tri

AU - Lusthom, Windy

AU - Sofiana, Anna

AU - Irawati, Kristiyani

AU - Trisari, Yunia

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - Amantadine HCl

KW - Bioequivalence

KW - LC-MS/MS

KW - Memantine HCl

KW - Pharmacokinetics

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SN - 0946-1965

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SP - 478

EP - 482

JO - International Journal of Clinical Pharmacology and Therapeutics

JF - International Journal of Clinical Pharmacology and Therapeutics

IS - 9

ER -

Bioequivalence of two memantine tablet formulations in healthy Indonesian subjects

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Keywords

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