Bioequivalence Test Applied to a New Lamivudine/Zidovudine Combined Formulation Tablet

SUMMARY. 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 (AUC0-τ) and absorption rate (Cmax) fell within 80 to 125 % for log-transformed parameters. Test and reference products present data of AUC0-τ, Cmax referents to lamivudine and data of ASC ∞ referents to zidovudine, in agreement of these limits. The result of Cmax (CI 90%) to zidovudine was: 116 % (90-141%), it has confirm that the zidovudine has high individual variability of absorption