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Bioequivalence Evaluation of Two Brands of Etoricoxib 120mg Tablets (Etoricoxib-SAJA & ARCOXIA®) – in Healthy Human Volunteers
Authors: Omaima N. Najib, Rana Hassan, Bassam Alwadi, Nasir M. Idkaidek, Naji M. Najib
Number of views: 1224
A randomized, two-way, crossover study was conducted in 34 fasting, healthy, male
volunteers to compare the bioavailability of two brands of etoricoxib 120mg tablets; Etoricoxib-SAJA
(Saudi Arabian Japanese Pharmaceutical Company, Saudi Arabia) as test and ARCOXIA® (Merck
Sharp & Dohme Ltd, UK) as reference product. The study was performed at the International
Pharmaceutical Research Centre (IPRC), Amman, Jordan. The drug was administered with 240 ml
of water after a 10-h overnight fasting on two treatment days separated by 2-weeks washout period.
After oral dosing, serial blood samples were collected for a period of 72 h. Plasma harvested from
blood was analyzed for etoricoxib by validated HPLC method with UV-visible detector capable to
detect etoricoxib in the range of 30-3000 ng/ml with limit of quantitation of 30.0 ng/ml. The
pharmacokinetic parameters including truncated AUC0→72, Cmax and Tmax were determined from
plasma concentrations of both formulations and found to be in good agreement with reported values.
Truncated AUC0→72 and Cmax were tested for bioequivalence after log-transformation of data.
No significant difference was found based on ANOVA; 90% confidence interval 95.72 -102.48 % for
AUC0→72, 89.76-106.81 % for Cmax of test/reference ratio for these parameters were found within
bioequivalence acceptance range of 80–125%. Based on these statistical inferences, it was concluded
that Etoricoxib-SAJA is bioequivalent to ARCOXIA®.