%0 Journal Article %1 sabrina_akter_tushi_2022_7181346 %A Tushi, Sabrina Akter %A Sahana, Nithon Chandra %A Bhowmik, Uttom Kumar %A Reza, Alimur %A Akram, Arifa %D 2022 %J World Journal of Biology Pharmacy and Health Sciences %K Bioequivalence %N 3 %P 036–042 %R 10.30574/wjbphs.2022.11.3.0134 %T Bioequivalence study of two Esomeprazole40 mg MUPS tablets in healthy adult Bangladeshi human subjects %U https://wjbphs.com/content/bioequivalence-study-two-esomeprazole40-mg-mups-tablets-healthy-adult-bangladeshi-human %V 11 %X Background: The primary objective of this study is to investigate the bioequivalence of two formulations (test& reference) of Esomeprazole 40 mg MUPS Tablet in healthy, adult human subjects. Method: In this study, a single dose, two-sequence, two-way crossover randomized design was used to investigate the bioequivalence under fasting conditions. 14 healthy volunteers received the two formulations over the course of two treatment days, each followed by a seven-day washout period. Following the administration of a single dose of 40 mg of each formulation, blood samples were taken at predetermined time points and subjected to a validated LC-MS/MS method for Esomeprazole concentration analysis. The plasma concentration-time profiles of both formulations were used to determine the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞. Result: Pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ did not show any statistically significant differences. The 90 % confidence intervals of Cmax, AUC0-t, and AUC0-∞ for Esomeprazole was found 89.35% (82.27-97.03%), 107.61% (99.78-116.05%), and 107.72 (99.87-116.20%) respectively which is within predetermined bioequivalence acceptance limits of 80 - 125 %. Conclusion: In terms of absorption rate and extent, the test product of Beximcopharmaceuticals has met the regulatory requirements for bioequivalence with the reference product Nexium MUPS.

@article{sabrina_akter_tushi_2022_7181346, abstract = {Background: The primary objective of this study is to investigate the bioequivalence of two formulations (test& reference) of Esomeprazole 40 mg MUPS Tablet in healthy, adult human subjects. Method: In this study, a single dose, two-sequence, two-way crossover randomized design was used to investigate the bioequivalence under fasting conditions. 14 healthy volunteers received the two formulations over the course of two treatment days, each followed by a seven-day washout period. Following the administration of a single dose of 40 mg of each formulation, blood samples were taken at predetermined time points and subjected to a validated LC-MS/MS method for Esomeprazole concentration analysis. The plasma concentration-time profiles of both formulations were used to determine the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞. Result: Pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ did not show any statistically significant differences. The 90 % confidence intervals of Cmax, AUC0-t, and AUC0-∞ for Esomeprazole was found 89.35% (82.27-97.03%), 107.61% (99.78-116.05%), and 107.72 (99.87-116.20%) respectively which is within predetermined bioequivalence acceptance limits of 80 - 125 %. Conclusion: In terms of absorption rate and extent, the test product of Beximcopharmaceuticals has met the regulatory requirements for bioequivalence with the reference product Nexium MUPS.}, added-at = {2022-11-14T15:36:27.000+0100}, author = {Tushi, Sabrina Akter and Sahana, Nithon Chandra and Bhowmik, Uttom Kumar and Reza, Alimur and Akram, Arifa}, biburl = {https://www.bibsonomy.org/bibtex/25c024895cd08d0f66c00b56ae87c1c60/wjbphsjournal}, doi = {10.30574/wjbphs.2022.11.3.0134}, interhash = {62108e9331c235b0a69e140c05ba43e7}, intrahash = {5c024895cd08d0f66c00b56ae87c1c60}, issn = {2582-5542}, journal = {{World Journal of Biology Pharmacy and Health Sciences}}, keywords = {Bioequivalence}, month = sep, number = 3, pages = {036–042}, timestamp = {2022-11-14T15:36:27.000+0100}, title = {Bioequivalence study of two Esomeprazole40 mg MUPS tablets in healthy adult Bangladeshi human subjects}, url = {https://wjbphs.com/content/bioequivalence-study-two-esomeprazole40-mg-mups-tablets-healthy-adult-bangladeshi-human}, volume = 11, year = 2022 }