Bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy Indian subjects

Bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy Indian subjects

Objective: This study presents the results of two-period, two-treatment crossover investigations on 24 healthy Indian male subjects to assess the bioequivalence of two oral formulations containing 400 mg of dexibuprofen (CAS 51146-56-6). An attempt was also made to study the pharmacokinetics of dexi...

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Main Authors: Mandal, Uttam, Das, Ayan, Agarwal, Sangita, Chakraborty, Uday, Nandi, Utpal, Chatterjee, Tapas Kumar, Pal, Tapan Kumar
Format: Article
Language:English
Published: Editio Cantor Verlag GmbH 2008
Subjects:
RS Pharmacy and materia medica
Online Access:http://irep.iium.edu.my/28421/
http://irep.iium.edu.my/28421/1/DEXIBUPROFEN_ARZENIMETAL.pdf
id iium-28421
recordtype eprints
spelling iium-284212013-08-26T15:21:06Z http://irep.iium.edu.my/28421/ Bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy Indian subjects Mandal, Uttam Das, Ayan Agarwal, Sangita Chakraborty, Uday Nandi, Utpal Chatterjee, Tapas Kumar Pal, Tapan Kumar RS Pharmacy and materia medica Objective: This study presents the results of two-period, two-treatment crossover investigations on 24 healthy Indian male subjects to assess the bioequivalence of two oral formulations containing 400 mg of dexibuprofen (CAS 51146-56-6). An attempt was also made to study the pharmacokinetics of dexibuprofen in the local population of Indian origin.Method: Both of the formulations were administered orally as a single dose separated by a one-week washout period. The concentration of dexibuprofen in plasma was determined by a validated HPLC method with UV detection using carbamazepine as internal standard. The formulations were compared using the parameters area under the plasma concentration-time curve (AUC0-t), area under the plasma concentration-time curve from zero to infinity (AUC0-∞), peak plasma concentration (Cmax), and time to reach peak plasma concentration (tmax).Results: The results of this investigation indicated that there were no statistically significant differences between the logarithmically transformed AUC0-∞ and Cmax values of the two preparations. The 90 % confidence interval for the ratio of the logarithmically transformed AUC0-t, AUC0-∞ and Cmax were within the bioequivalence limit of 0.8-1.25 and the relative bioavailability of the test formulation was 99.04 % of that of reference formulationjok?.Conclusion: Thus, these findings clearly indicate that the two formulations are bioequivalent in terms of rate and extent of drug absorption. Both preparations were well tolerated with no adverse reactions observed throughout the study. Editio Cantor Verlag GmbH 2008 Article PeerReviewed application/pdf en http://irep.iium.edu.my/28421/1/DEXIBUPROFEN_ARZENIMETAL.pdf Mandal, Uttam and Das, Ayan and Agarwal, Sangita and Chakraborty, Uday and Nandi, Utpal and Chatterjee, Tapas Kumar and Pal, Tapan Kumar (2008) Bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy Indian subjects. Arzneimittel-Forschung (Drug Research), 58 (7). pp. 342-347. ISSN 00044172
repository_type Digital Repository
institution_category Local University
institution International Islamic University Malaysia
building IIUM Repository
collection Online Access
language English
topic RS Pharmacy and materia medica
spellingShingle RS Pharmacy and materia medica
Mandal, Uttam
Das, Ayan
Agarwal, Sangita
Chakraborty, Uday
Nandi, Utpal
Chatterjee, Tapas Kumar
Pal, Tapan Kumar
Bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy Indian subjects
description Objective: This study presents the results of two-period, two-treatment crossover investigations on 24 healthy Indian male subjects to assess the bioequivalence of two oral formulations containing 400 mg of dexibuprofen (CAS 51146-56-6). An attempt was also made to study the pharmacokinetics of dexibuprofen in the local population of Indian origin.Method: Both of the formulations were administered orally as a single dose separated by a one-week washout period. The concentration of dexibuprofen in plasma was determined by a validated HPLC method with UV detection using carbamazepine as internal standard. The formulations were compared using the parameters area under the plasma concentration-time curve (AUC0-t), area under the plasma concentration-time curve from zero to infinity (AUC0-∞), peak plasma concentration (Cmax), and time to reach peak plasma concentration (tmax).Results: The results of this investigation indicated that there were no statistically significant differences between the logarithmically transformed AUC0-∞ and Cmax values of the two preparations. The 90 % confidence interval for the ratio of the logarithmically transformed AUC0-t, AUC0-∞ and Cmax were within the bioequivalence limit of 0.8-1.25 and the relative bioavailability of the test formulation was 99.04 % of that of reference formulationjok?.Conclusion: Thus, these findings clearly indicate that the two formulations are bioequivalent in terms of rate and extent of drug absorption. Both preparations were well tolerated with no adverse reactions observed throughout the study.
format Article
author Mandal, Uttam
Das, Ayan
Agarwal, Sangita
Chakraborty, Uday
Nandi, Utpal
Chatterjee, Tapas Kumar
Pal, Tapan Kumar
author_facet Mandal, Uttam
Das, Ayan
Agarwal, Sangita
Chakraborty, Uday
Nandi, Utpal
Chatterjee, Tapas Kumar
Pal, Tapan Kumar
author_sort Mandal, Uttam
title Bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy Indian subjects
title_short Bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy Indian subjects
title_full Bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy Indian subjects
title_fullStr Bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy Indian subjects
title_full_unstemmed Bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy Indian subjects
title_sort bioequivalence study of two formulations containing 400 mg dexibuprofen in healthy indian subjects
publisher Editio Cantor Verlag GmbH
publishDate 2008
url http://irep.iium.edu.my/28421/
http://irep.iium.edu.my/28421/1/DEXIBUPROFEN_ARZENIMETAL.pdf
first_indexed 2023-09-18T20:41:56Z
last_indexed 2023-09-18T20:41:56Z
_version_ 1777409422634516480

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