Estudio de bioequivalencia: formulaciones genéricas y comerciales de estaduvine, lamiduvine, zidovudine e indinavir en pacientes cubanos infectados con VIH

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