Pharmacokinetic equivalence study of two formulations of the anticonvulsant pregabalin

Raymond R Tjandrawinata,1 Effi Setiawati,2 Ratih Sofia Ika Putri,2 Vincent Angga Gunawan,2 Fenny Ong,1 Liana W Susanto,1 Dwi Nofiarny11Dexa Laboratories of Biomolecular Sciences, Cikarang, West Java, Indonesia; 2PT Equilab International Bioavailability and Bioequivalence Laboratory, Jakarta, Indones...

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Autores principales:	Tjandrawinata RR, Setiawati E, Putri RSI, Gunawan VA, Ong F, Susanto LW, Nofiarny D
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/0177166afbd64b0ebda8d85e6ab4ab99
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spelling	oai:doaj.org-article:0177166afbd64b0ebda8d85e6ab4ab992021-12-02T06:36:09ZPharmacokinetic equivalence study of two formulations of the anticonvulsant pregabalin1179-1438https://doaj.org/article/0177166afbd64b0ebda8d85e6ab4ab992015-04-01T00:00:00Zhttp://www.dovepress.com/pharmacokinetic-equivalence-study-of-two-formulations-of-the-anticonvu-peer-reviewed-article-CPAAhttps://doaj.org/toc/1179-1438Raymond R Tjandrawinata,1 Effi Setiawati,2 Ratih Sofia Ika Putri,2 Vincent Angga Gunawan,2 Fenny Ong,1 Liana W Susanto,1 Dwi Nofiarny11Dexa Laboratories of Biomolecular Sciences, Cikarang, West Java, Indonesia; 2PT Equilab International Bioavailability and Bioequivalence Laboratory, Jakarta, IndonesiaPurpose: The present study was conducted to evaluate whether the bioavailability of pregabalin capsules 150 mg manufactured by PT Dexa Medica was equivalent to the reference formulation.Methods: This was a randomized, open-label, two-period, two-sequence, and crossover study under fasting condition, with a 1-week washout period. Plasma concentrations of pregabalin from 20 subjects were determined by using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) detection method. Pharmacokinetic parameters assessed in this study were: area under the plasma concentration–time curve from time zero to last observed quantifiable concentration (AUC0–t), area under the plasma concentration–time curve from time zero to infinity (AUC0–∞), maximum plasma concentration (Cmax), time to maximum plasma concentration (tmax), and terminal half-life (t1/2). The 90% confidence intervals (CIs) for the geometric mean ratios of test formulation/reference formulation were calculated for the AUC and Cmax parameters; while tmax difference was analyzed nonparametrically on the original data using the Wilcoxon matched-pairs test, and t1/2 difference was analyzed using Student's paired t-test.Results: The mean (standard deviation [SD]) AUC0–t, AUC0–∞, Cmax, and t1/2 of pregabalin from the test formulation were 27,845.86 (4,508.27) ng·h/mL, 28,311.70 (4,790.55) ng·h/mL, 3,999.71 (801.52) ng/mL, and 5.66 (1.20) hours, respectively; while the mean (SD) AUC0–t, AUC0–∞, Cmax, and t1/2 of pregabalin from the reference formulation were 27,398.12 (4,266.28) ng·h/mL, 27,904.24 (4,507.31) ng·h/mL, 3,849.50 (814.50) ng/mL, and 5.87 (1.25) hours, respectively. The median (range) tmax of pregabalin from the test formulation and reference formulation was 1.00 (0.67–2.00) hours and 1.00 (0.67–3.00) hours, respectively. The 90% CIs for the geometric mean ratios of test formulation/reference formulation for pregabalin were 101.54% (98.75%–104.41%) for AUC0–t, 101.35% (98.66%–104.11%) for AUC0–∞, and 104.19% (98.75%–109.93%) for Cmax.Conclusion: The study concluded that the two formulations of pregabalin capsules studied were bioequivalent.Keywords: antiepileptic, bioavailability, bioequivalence, generic productTjandrawinata RRSetiawati EPutri RSIGunawan VAOng FSusanto LWNofiarny DDove Medical PressarticleTherapeutics. PharmacologyRM1-950ENClinical Pharmacology: Advances and Applications, Vol 2015, Iss default, Pp 69-75 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Therapeutics. Pharmacology RM1-950
spellingShingle	Therapeutics. Pharmacology RM1-950 Tjandrawinata RR Setiawati E Putri RSI Gunawan VA Ong F Susanto LW Nofiarny D Pharmacokinetic equivalence study of two formulations of the anticonvulsant pregabalin
description	Raymond R Tjandrawinata,1 Effi Setiawati,2 Ratih Sofia Ika Putri,2 Vincent Angga Gunawan,2 Fenny Ong,1 Liana W Susanto,1 Dwi Nofiarny11Dexa Laboratories of Biomolecular Sciences, Cikarang, West Java, Indonesia; 2PT Equilab International Bioavailability and Bioequivalence Laboratory, Jakarta, IndonesiaPurpose: The present study was conducted to evaluate whether the bioavailability of pregabalin capsules 150 mg manufactured by PT Dexa Medica was equivalent to the reference formulation.Methods: This was a randomized, open-label, two-period, two-sequence, and crossover study under fasting condition, with a 1-week washout period. Plasma concentrations of pregabalin from 20 subjects were determined by using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) detection method. Pharmacokinetic parameters assessed in this study were: area under the plasma concentration–time curve from time zero to last observed quantifiable concentration (AUC0–t), area under the plasma concentration–time curve from time zero to infinity (AUC0–∞), maximum plasma concentration (Cmax), time to maximum plasma concentration (tmax), and terminal half-life (t1/2). The 90% confidence intervals (CIs) for the geometric mean ratios of test formulation/reference formulation were calculated for the AUC and Cmax parameters; while tmax difference was analyzed nonparametrically on the original data using the Wilcoxon matched-pairs test, and t1/2 difference was analyzed using Student's paired t-test.Results: The mean (standard deviation [SD]) AUC0–t, AUC0–∞, Cmax, and t1/2 of pregabalin from the test formulation were 27,845.86 (4,508.27) ng·h/mL, 28,311.70 (4,790.55) ng·h/mL, 3,999.71 (801.52) ng/mL, and 5.66 (1.20) hours, respectively; while the mean (SD) AUC0–t, AUC0–∞, Cmax, and t1/2 of pregabalin from the reference formulation were 27,398.12 (4,266.28) ng·h/mL, 27,904.24 (4,507.31) ng·h/mL, 3,849.50 (814.50) ng/mL, and 5.87 (1.25) hours, respectively. The median (range) tmax of pregabalin from the test formulation and reference formulation was 1.00 (0.67–2.00) hours and 1.00 (0.67–3.00) hours, respectively. The 90% CIs for the geometric mean ratios of test formulation/reference formulation for pregabalin were 101.54% (98.75%–104.41%) for AUC0–t, 101.35% (98.66%–104.11%) for AUC0–∞, and 104.19% (98.75%–109.93%) for Cmax.Conclusion: The study concluded that the two formulations of pregabalin capsules studied were bioequivalent.Keywords: antiepileptic, bioavailability, bioequivalence, generic product
format	article
author	Tjandrawinata RR Setiawati E Putri RSI Gunawan VA Ong F Susanto LW Nofiarny D
author_facet	Tjandrawinata RR Setiawati E Putri RSI Gunawan VA Ong F Susanto LW Nofiarny D
author_sort	Tjandrawinata RR
title	Pharmacokinetic equivalence study of two formulations of the anticonvulsant pregabalin
title_short	Pharmacokinetic equivalence study of two formulations of the anticonvulsant pregabalin
title_full	Pharmacokinetic equivalence study of two formulations of the anticonvulsant pregabalin
title_fullStr	Pharmacokinetic equivalence study of two formulations of the anticonvulsant pregabalin
title_full_unstemmed	Pharmacokinetic equivalence study of two formulations of the anticonvulsant pregabalin
title_sort	pharmacokinetic equivalence study of two formulations of the anticonvulsant pregabalin
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/0177166afbd64b0ebda8d85e6ab4ab99
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Pharmacokinetic equivalence study of two formulations of the anticonvulsant pregabalin

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