Titre du document / Document title

Bioequivalence study of generic acyclovir compared with the brand name Acyclovir®

Auteur(s) / Author(s)

ROJANASTHIEN Noppamas ⁽¹⁾ ; KUMSORN Boonyium ⁽¹⁾ ; YUEN KAH HAY ⁽²⁾ ; TEEKACHUNHATEAN Supanimit ⁽¹⁾ ; CHAICHANA Nuchanart ⁽¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, THAILANDE
⁽²⁾ School of Pharmaceutical Sciences, University of Science Malaysia, 11800 Minden, Penang, MALAISIE

Résumé / Abstract

The bioequivalence study of 200-mg generic acyclovir was conducted in healthy males. The reference Zovirax® and the test Zevin® were administered as a single oral dose after an overnight fast in a two-period, crossover design separated by 1 week. Serial blood samples were collected over a period of 24 hours. Plasma acyclovir concentrations were determined by HPLC and the pharmacokinetic parameters were analyzed by non-compartmental analysis. Results: The t_1/2 for the test (4.5 ± 2.4 h) and Zovirax® (3.9 ± 2.6 h) were comparable. The analysis of variance was carried out and the median T_max (1.50 h) for the test was not statistically difference from Zovirax®. The mean (90% CI) of the AUC_0-∞ and the C_max ratios for (Test/Reference) were 0.95 (0.83 - 1.09) and 0.95 (0.83 - 1.10), respectively. These values fell within the bioequivalence criteria of 0.80 - 1.25, thus it was concluded that Zevin® and Zovirax® were bioequivalence.

Revue / Journal Title

Chot Mai Het Thang Phaet   ISSN 0125-2208   CODEN JMTHBU 

Source / Source

2002, vol. 85, n^o10, pp. 1121-1129 [9 page(s) (article)] (14 ref.)

Langue / Language

Anglais

Editeur / Publisher

Medical Association of Thailand, Bangkok, THAILANDE  (1919) (Revue)

Mots-clés anglais / English Keywords

Purine nucleoside ; Acyclic nucleoside ; Bioavailability ; Concentration ; High performance ; Liquid chromatography ; Generic drug ; Bioequivalence ; Pharmacokinetics ; Pharmacology ; Experimental study ; Volunteer ; Human ; Antiviral ; Aciclovir ;

Mots-clés français / French Keywords

Purine nucléoside ; Nucléoside acyclique ; Biodisponibilité ; Concentration ; Haute performance ; Chromatographie phase liquide ; Médicament générique ; Bioéquivalence ; Pharmacocinétique ; Pharmacologie ; Etude expérimentale ; Volontaire ; Homme ; Antiviral ; Aciclovir ;

Mots-clés espagnols / Spanish Keywords

Purina nucleósido ; Nucleósido acíclico ; Biodisponibilidad ; Concentración ; Alto rendimiento ; Cromatografía fase líquida ; Medicamento genérico ; Bioequivalencia ; Farmacocinética ; Farmacología ; Estudio experimental ; Voluntario ; Hombre ; Antiviral ; Aciclovir ;

Localisation / Location

INIST-CNRS, Cote INIST : 17480, 35400010572163.0120