Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib

Raymond R Tjandrawinata,1 Arini Setiawati,2 Dwi Nofiarny,1 Liana W Susanto,1 Effi Setiawati3 1Dexa Laboratories of Biomolecular Sciences Unit, Dexa Medica Group, Cikarang, West Java, Indonesia; 2Department of Pharmacology and Therapeutics, Medical Faculty, University of Indonesia, Jakarta, Indonesia...

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Autores principales:	Tjandrawinata RR, Setiawati A, Nofiarny D, Susanto LW, Setiawati E
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	bioavailability bioequivalence etoricoxib non-steroidal anti-inflammatory drug selective cyclooxygenase-2 inhibitor Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/ffa0af854e66411f82e0a722b4e6620e
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spelling	oai:doaj.org-article:ffa0af854e66411f82e0a722b4e6620e2021-12-02T05:40:40ZPharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib1179-1438https://doaj.org/article/ffa0af854e66411f82e0a722b4e6620e2018-04-01T00:00:00Zhttps://www.dovepress.com/pharmacokinetic-equivalence-study-of-nonsteroidal-anti-inflammatory-dr-peer-reviewed-article-CPAAhttps://doaj.org/toc/1179-1438Raymond R Tjandrawinata,1 Arini Setiawati,2 Dwi Nofiarny,1 Liana W Susanto,1 Effi Setiawati3 1Dexa Laboratories of Biomolecular Sciences Unit, Dexa Medica Group, Cikarang, West Java, Indonesia; 2Department of Pharmacology and Therapeutics, Medical Faculty, University of Indonesia, Jakarta, Indonesia; 3Bioavailability and Bioequivalence Laboratory Unit, PT Equilab International, Jakarta, Indonesia Purpose: The current study aimed to evaluate whether a generic product of etoricoxib 120 mg film-coated tablet (the test drug) was bioequivalent to the reference product (Arcoxia® film-coated tablet 120 mg).Methods: This was a randomized, open-label, two-sequence, crossover study under fasting condition, with a 14-day washout period, involving 26 healthy adult male and female subjects. Blood samples were taken and analyzed for plasma concentrations of etoricoxib (Chemical Abstracts Service [CAS] 202409-33-4) using a high-pressure liquid chromatography–ultraviolet detector (HPLC-UV) system capable of measuring etoricoxib concentrations ranging from 5.00 to 5002.90 ng/mL, with the lowest limit of quantitation of 5.00 ng/mL. A noncompartmental method was used to determine the pharmacokinetic parameters of a single-dose administration of the drug, including the area under plasma concentration–time curve from time zero to the time of last observed concentration (AUC0-t), the area under plasma concentration–time curve from time zero to infinity (AUC0-∞), the maximum plasma concentration (Cmax), the time to reach the maximum plasma concentration (tmax), and the terminal half-life (t½).Results: After a single-dose administration of etoricoxib 120 mg film-coated tablet, the mean (SD) values for the AUC0-72h and Cmax of the test drug were 45913.42 (13142.19) ng·h/mL and 3155.93 (752.81) ng/mL, respectively; the values for the reference drug were 44577.20 (13541.85) ng⋅h/mL and 2915.13 (772.81) ng/mL, respectively. The geometric mean ratios (90% CIs) of the test drug/reference drug were 103.40% (98.70%–108.32%) for AUC0-72h and 109.26% (100.18%–119.18%) for Cmax. No clinically significant differences in tmax and t½values were found between the test drug and the reference drug. No adverse events were experienced by the subjects during this study.Conclusion: The present study demonstrated that the evaluated generic etoricoxib 120 mg film-coated tablets were bioequivalent to the reference drug. Keywords: bioavailability, bioequivalence, etoricoxib, nonsteroidal anti-inflammatory drug, selective cyclooxygenase-2 inhibitor Tjandrawinata RRSetiawati ANofiarny DSusanto LWSetiawati EDove Medical Pressarticlebioavailabilitybioequivalenceetoricoxibnon-steroidal anti-inflammatory drugselective cyclooxygenase-2 inhibitorTherapeutics. PharmacologyRM1-950ENClinical Pharmacology: Advances and Applications, Vol Volume 10, Pp 43-51 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	bioavailability bioequivalence etoricoxib non-steroidal anti-inflammatory drug selective cyclooxygenase-2 inhibitor Therapeutics. Pharmacology RM1-950
spellingShingle	bioavailability bioequivalence etoricoxib non-steroidal anti-inflammatory drug selective cyclooxygenase-2 inhibitor Therapeutics. Pharmacology RM1-950 Tjandrawinata RR Setiawati A Nofiarny D Susanto LW Setiawati E Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib
description	Raymond R Tjandrawinata,1 Arini Setiawati,2 Dwi Nofiarny,1 Liana W Susanto,1 Effi Setiawati3 1Dexa Laboratories of Biomolecular Sciences Unit, Dexa Medica Group, Cikarang, West Java, Indonesia; 2Department of Pharmacology and Therapeutics, Medical Faculty, University of Indonesia, Jakarta, Indonesia; 3Bioavailability and Bioequivalence Laboratory Unit, PT Equilab International, Jakarta, Indonesia Purpose: The current study aimed to evaluate whether a generic product of etoricoxib 120 mg film-coated tablet (the test drug) was bioequivalent to the reference product (Arcoxia® film-coated tablet 120 mg).Methods: This was a randomized, open-label, two-sequence, crossover study under fasting condition, with a 14-day washout period, involving 26 healthy adult male and female subjects. Blood samples were taken and analyzed for plasma concentrations of etoricoxib (Chemical Abstracts Service [CAS] 202409-33-4) using a high-pressure liquid chromatography–ultraviolet detector (HPLC-UV) system capable of measuring etoricoxib concentrations ranging from 5.00 to 5002.90 ng/mL, with the lowest limit of quantitation of 5.00 ng/mL. A noncompartmental method was used to determine the pharmacokinetic parameters of a single-dose administration of the drug, including the area under plasma concentration–time curve from time zero to the time of last observed concentration (AUC0-t), the area under plasma concentration–time curve from time zero to infinity (AUC0-∞), the maximum plasma concentration (Cmax), the time to reach the maximum plasma concentration (tmax), and the terminal half-life (t½).Results: After a single-dose administration of etoricoxib 120 mg film-coated tablet, the mean (SD) values for the AUC0-72h and Cmax of the test drug were 45913.42 (13142.19) ng·h/mL and 3155.93 (752.81) ng/mL, respectively; the values for the reference drug were 44577.20 (13541.85) ng⋅h/mL and 2915.13 (772.81) ng/mL, respectively. The geometric mean ratios (90% CIs) of the test drug/reference drug were 103.40% (98.70%–108.32%) for AUC0-72h and 109.26% (100.18%–119.18%) for Cmax. No clinically significant differences in tmax and t½values were found between the test drug and the reference drug. No adverse events were experienced by the subjects during this study.Conclusion: The present study demonstrated that the evaluated generic etoricoxib 120 mg film-coated tablets were bioequivalent to the reference drug. Keywords: bioavailability, bioequivalence, etoricoxib, nonsteroidal anti-inflammatory drug, selective cyclooxygenase-2 inhibitor
format	article
author	Tjandrawinata RR Setiawati A Nofiarny D Susanto LW Setiawati E
author_facet	Tjandrawinata RR Setiawati A Nofiarny D Susanto LW Setiawati E
author_sort	Tjandrawinata RR
title	Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib
title_short	Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib
title_full	Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib
title_fullStr	Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib
title_full_unstemmed	Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib
title_sort	pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/ffa0af854e66411f82e0a722b4e6620e
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Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib

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