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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Österreichische Apotheker-Verlagsgesellschaft
2013
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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. |
format | Online Article Text |
id | pubmed-3791939 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Österreichische Apotheker-Verlagsgesellschaft |
record_format | MEDLINE/PubMed |
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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