Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers
Published in: Volume 10 / Year 2021 / Issue 3 Category: Original Research
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
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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