%0 Journal Article
%T Estudio de bioequivalencia: formulaciones gen¨¦ricas y comerciales de estaduvine, lamiduvine, zidovudine e indinavir en pacientes cubanos infectados con VIH
%A Tarinas Reyes
%A Alicia
%A T¨¢panes Peraza
%A Rolando D
%A Gil del Valle
%A Lizette
%A Gonz¨¢lez Rubio
%A Daniel
%A Castro Peraza
%A Osvaldo
%A Padr¨®n
%A Alejandro Sa¨²l
%A Mart¨ªnez Rodr¨ªguez
%A Alina
%A Orta Guti¨¦rrez
%A Mylai
%A Ferrer Linares
%A Geisy
%A P¨¦rez ¨¢vila
%A Jorge
%J Revista Cubana de Farmacia
%D 2006
%I ECIMED
%X objective: the present study describes the determination of the bioequivalence of the cuban generic and trade formulations of stavudine, lamivudine, zidovudine, and indinavir. design: the bioequivalence of each antiretroviral drug (test and reference formulations) was determined in 13 or 14subjects by means of a randomizedcrossover blind study with a wash-outperiod of ten days. methods: the plasma concentrations were monitored over a period of 12 h after drug administration using a validated hplc method. the pharmacokinetic parameters were determined by using winnolin professional software, version 2.1. the comparison of the pharmacokinetic parameters was made at 95 % confidence interval using the ncss 2000 and pass 2000 trial software (paired t-test, null hypothesis).the bioequivalence study was conducted by the eqivtest software of statistical solutions. anova was utilized with 90 % confidence interval. results: the present study showed that no significant differences were observed in the means of auc0-12, auc0-£¤, c max, and t max of both formulations of stavudine, lamivudine zidovudine, and indinavir. it wasconcluded that the studied pharmacokinetic parameters are withinthe established range. the ranges for cmax, auc0-12, and auc0-£¤ were 80-125 %, whereasthe range for cmax of zidovudine was 70-143 %. conclusion: these results prove that the cuban generic antiretroviralsare bioequivalent to their respective innovatory products in terms ofthe rate and extent of absorption
%K antiretroviral
%K bioequivalence
%K hplc
%K hiv
%K generic drugs.
%U http://scielo.sld.cu/scielo.php?script=sci_abstract&pid=S0034-75152006000200002&lng=en&nrm=iso&tlng=en