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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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 |
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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 |
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