Bioequivalence test applied to a new lamivudine/zidovudine combined formulation tablet

Abstract

A double-center, open-label, two-way crossover study was conducted in 24 healthy volunteers to assess the bioequivalence of a combined lamivudine/zidovudine tablet related to a reference and test drug products. The volunteers were randomly assigned to receive one lamivudine/zidovudine combination tablet of reference or test product with 7-days washout period between. Blood samples were collected up to 36 h post dose. Pharmacokinetic parameters were estimated. Drug products were bioequivalent if 90% confidence intervals for the ratio of least squares (CI 90%) means are under plasma concentration-time curve (AUC_0-τ ) and absorption rate (C_max) fell within 80 to 125% for log-transformed parameters. Test and reference products present data of AUC_0-τ , C_max referents to lamivudine and data of ASC∞ referents to zidovudine, in agreement of these limits. The result of C_max (CI 90%) to zidovudine was: 116% (90- 141%), it has confirm that the zidovudine has high individual variability of absorption.