Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers

Published in: Volume 10 / Year 2021 / Issue 3
Category: Original Research
Visits: 142 total, 3 today
Keywords: bioequivalence, COX-2 inhibitor, etoricoxib, generics

Author byline as per print journal:
Shalini Harikrishnan, BSc; Ka-Liong Tan, DPhil; Kar Ming Yee, BPharm; Alia Shagari Ahmad Shukri, MSc; N Ramana Reddy, MBBS; Chewy Wuei Leong, PhD

Abstract
Introduction/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.
Method: 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 therefore found to be bioequivalent with respect to the reference drug, according to ASEAN bioequivalence guidelines.

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.

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