Nishalini HarikrishnanKa-Liong TanKar Ming YeeAlia Shaari Ahmad ShukriNalla Ramana ReddyChuei Wuei Leong2024-05-272024-05-2720212022-1-272033-67722224-1110.5639/gabij.2021.1003.013http://gabi-journal.net/pharmacokinetics-and-bioequivalence-of-generic-etoricoxib-in-healthy-volunteers.htmlhttps://oarep.usim.edu.my/handle/123456789/3232Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(3):113-8 DOI: 10.5639/gabij.2021.1003.013Introduction/Study Objectives: A bioequivalence study was performed to compare the pharmacological profile of innovator etoricoxib (ETO) with a newly developed generic ETO, both in a 120 mg tablet formulation. A dissolution study was conducted to optimize the formulation process before evaluating physical changes in the active pharmaceutical ingredient and the formulated product. Methods: This was a randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, two-way crossover, truncated bioequivalence study involving a washout period of ten days. A total of 26 healthy male volunteers were recruited. The pharmacokinetic profile of the test formulation was compared with the reference formulation. Results/Discussion: The pharmacokinetic parameters of ETO were calculated based on the plasma drug concentration-time profile using non-compartmental analysis to determine its safety profile and tolerability. The Test/Reference (T/R) ratio of ETO was 104.36% (90% confidence interval (CI): 98.30%–110.80%) for area under curve (AUC)0-72 while the T/R ratio of maximum concentration (Cmax) was 101.39% (92.15%–111.56%). The 90% CI of the Cmax and AUC0-72 of ETO were within acceptable bioequivalence limits of 80%–125%. All values were within the predetermined limits of the Association of Southeast Asian Nation (ASEAN) bioequivalence guidelines. Conclusion: The test formulation was found to be bioequivalent with respect to the reference drug, according to ASEAN bioequivalence guidelines.enbioequivalence, COX-2 inhibitor, etoricoxib, genericsArticle113118103