A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States

To assess the bioequivalence of two extended-release tablets of donepezil 23 mg, open label, randomized, single-dose, two-sequence, two-period crossover studies under fasting (n=74) and fed (n=94) conditions in healthy adult human volunteers were conducted. Subjects were randomized to either of the...

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Autores principales: Gadiko, Chaitanya, Tippabhotla, Sudhakar Koundinya, Thota, Satyanarayana, Battula, Ramakrishna, Khan, Sohel Md., Vobalaboina, Venkateswarlu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Österreichische Apotheker-Verlagsgesellschaft 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3791939/
https://www.ncbi.nlm.nih.gov/pubmed/24106673
http://dx.doi.org/10.3797/scipharm.1302-13
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author Gadiko, Chaitanya
Tippabhotla, Sudhakar Koundinya
Thota, Satyanarayana
Battula, Ramakrishna
Khan, Sohel Md.
Vobalaboina, Venkateswarlu
author_facet Gadiko, Chaitanya
Tippabhotla, Sudhakar Koundinya
Thota, Satyanarayana
Battula, Ramakrishna
Khan, Sohel Md.
Vobalaboina, Venkateswarlu
author_sort Gadiko, Chaitanya
collection PubMed
description To assess the bioequivalence of two extended-release tablets of donepezil 23 mg, open label, randomized, single-dose, two-sequence, two-period crossover studies under fasting (n=74) and fed (n=94) conditions in healthy adult human volunteers were conducted. Subjects were randomized to either of the two treatment arms (test or reference) separated by a washout period of 28 days. Blood samples were collected up to 72 h post-dose and plasma samples were analyzed for donepezil using a validated LC-MS/MS method. Pharmacokinetic parameters were derived using a non-compartmental approach. Bioequivalence was evaluated in 69 subjects in the fasting study, and 71 subjects in the fed study. In the fasting study, the 90% CI of C(max) and AUC(0-72) were 82.50–90.10 and 92.38–98.60, respectively. Corresponding values in the fed study were 91.82–98.05 and 97.27–100.27. Based on the results, the test product (donepezil) met the US regulatory criteria of bioequivalence relative to the reference product (Aricept(®)) under both fasting and fed conditions.
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spelling pubmed-37919392013-10-08 A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States Gadiko, Chaitanya Tippabhotla, Sudhakar Koundinya Thota, Satyanarayana Battula, Ramakrishna Khan, Sohel Md. Vobalaboina, Venkateswarlu Sci Pharm Research Article To assess the bioequivalence of two extended-release tablets of donepezil 23 mg, open label, randomized, single-dose, two-sequence, two-period crossover studies under fasting (n=74) and fed (n=94) conditions in healthy adult human volunteers were conducted. Subjects were randomized to either of the two treatment arms (test or reference) separated by a washout period of 28 days. Blood samples were collected up to 72 h post-dose and plasma samples were analyzed for donepezil using a validated LC-MS/MS method. Pharmacokinetic parameters were derived using a non-compartmental approach. Bioequivalence was evaluated in 69 subjects in the fasting study, and 71 subjects in the fed study. In the fasting study, the 90% CI of C(max) and AUC(0-72) were 82.50–90.10 and 92.38–98.60, respectively. Corresponding values in the fed study were 91.82–98.05 and 97.27–100.27. Based on the results, the test product (donepezil) met the US regulatory criteria of bioequivalence relative to the reference product (Aricept(®)) under both fasting and fed conditions. Österreichische Apotheker-Verlagsgesellschaft 2013 2013-04-25 /pmc/articles/PMC3791939/ /pubmed/24106673 http://dx.doi.org/10.3797/scipharm.1302-13 Text en © Gadiko et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m. b. H., Vienna, Austria. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Gadiko, Chaitanya
Tippabhotla, Sudhakar Koundinya
Thota, Satyanarayana
Battula, Ramakrishna
Khan, Sohel Md.
Vobalaboina, Venkateswarlu
A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States
title A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States
title_full A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States
title_fullStr A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States
title_full_unstemmed A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States
title_short A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States
title_sort randomized, crossover, single-dose bioequivalence study of two extended-release tablets of donepezil 23 mg in healthy human volunteers under fasting and fed states
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3791939/
https://www.ncbi.nlm.nih.gov/pubmed/24106673
http://dx.doi.org/10.3797/scipharm.1302-13
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