BIOAVAILABILITY AND PHARMACOKINETICS OF ACYCLOVIR TABLET PREPARATION

The bioavailability of a generic preparation of acyclovir (Avorax) was compared with the innovator product, Zovirax. Twelve healthy voluntee rs participated in the study, conducted according to a randomized, two -way crossover design. The preparations were compared using the parame ters area under the plasma concentration-time curve (AUC(0-infinity)), peak plasma concentration (C-max), and time to reach peak plasma conc entration (T-max). No statistically significant difference was observe d between the T-max or the logarithmic transformed AUC(0-infinity) and C-max values of the two preparations. In addition, the 90% confidence interval for the ratio of the logarithmic transformed AUC(0-infinity) values of Avorax over those of Zovirax was found to lie between 0.85 and 1.06, while that of the logarithmic transformed C-max values was b etween 0.95 and 1.25, being within the bioequivalence limit of 0.80-1. 25. Moreover, the elimination rate constant (k(e)), elimination half-l ife (t(1/2)), and apparent volume of distribution (V-d) values obtaine d with the two preparations were comparable and not significantly diff erent statistically.