Bioequivalence Study of Generic Acyclovir Compared with the Brand Name Acyclovir®

NOPPAMAS ROJANASTHIEN, M.D*, SUPANIMIT TEEKACHUNHATEAN, M.D*, BOONYIUM KUMSORN, M.S*, NUCHANART CHAICHANA, M.S*, YUEN KAH HAY,Ph.D.**

Affiliation : * Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand. ** School of Pharmaceutical Sciences, University of Science Malaysia, 11800 Minden, Penang, Malaysia.

AbstractThe bioequivalence study of 200-mg generic acyclovir was conducted in healthy males. The reference Zovirax® and the test Zevin® were administered as a single oral dose after an overnight fast in a two-period, crossover design separated by I week. Serial blood samples were collected over a period of 24 hours. Plasma acyclovir concentrations were determined by HPLC and the pharmacokinetic parameters were analyzed by non-compartmental analysis.
Results : The t112 for the test (4.5 ± 2.4 h) and Zovirax® (3.9 ± 2.6 h) were comparable. The analysis of variance was carried out and the median T (1.50 h) for the test was not statistically difference from Zovirax®. The mean (90% Cl) of the AUCO_ and the cmax ratios for (Reie~~ce) were 0.95 (0.83 - 1.09) and 0.95 (0.83 - 1.10), respectively. These values fell within the bioequivalence criteria of 0.80 - 1.25, thus it was concluded that Zevin® and Zovirax® were bioequivalence.

Keywords : Acyclovir, Bioequivalence, Zevin®, Zovirax®

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