Bioequivalence study of two formulations of acyclovir in healthy volunteers

Bioequivalence Study of Two Formulations of Acyclovir in Healthy Volunteers. The purpose of this study was to evaluate bioequivalence of two commercial 200 mg tablet formulations of acyclovir. The study was an open, randomized, two-period crossover trial with a 1-week washout interval. Blood samples were collected throughout a 16-h period after administration of reference product, Zovirax (R) and test product, Acyclovir to 32 fasting volunteers. A simple, accurate, precise and sensitive high-performance liquid chromatographic (HPLC) method with ultraviolet detection was developed and validated for quantification of acyclovir in plasma samples after liquid-liquid extraction. Bioequivalence between the products was determined by calculating 90% confidence intervals (90% I.C) for the ratio of C-max, AUC(0-t) and AUC(0-infinity) values for the test and reference products, using logarithmic transformed data. The 90% confidence intervals for the ratio Of C-max (83.86-105.83%), AUC(0-t) (86.67-111.379%) and (87.76-110.87%) values for the test and reference products are within the 80-125% interval, proposed by ANVISA. It was concluded that the two acyclovir formulations are bioequivalent in their rate and extent of absorption.