Modern Clinical Medicine Research
Bioequivalence Evaluation of Two Brands of Etoricoxib 120mg Tablets (Etoricoxib-SAJA & ARCOXIA®) – in Healthy Human Volunteers
Download PDF (188.6 KB) PP. 7 - 12 Pub. Date: April 13, 2017
Author(s)
- Omaima N. Najib*
College of Pharmacy, Philadelphia University, Amman, Jordan - Rana Hassan
International Pharmaceutical Research Center, Amman, Jordan - Bassam Alwadi
SAJA Pharmaceuticals, Jeddah, Saudi Arabia - Nasir M. Idkaidek
College of Pharmacy, University of Petra, Amman, Jordan - Naji M. Najib
International Pharmaceutical Research Center, Amman, Jordan
Abstract
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®.
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®.
Keywords
Etoricoxib, bioequivalence, pharmacokinetics
References
[1] Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 1990; 28: 72–78.
[2] Schulz HU, Steinijans VW. Striving for standards in bioequivalence assessment: a review. Int J Clin Pharmacol Ther Toxicol 1992; 30(Suppl.1): S1–S6.
[3] Kinetica, Version 5.1SP1, User Manual.
[4] Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations. March 2003. Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857, USA.