J Med Assoc Thai 2002; 85 (10):1121

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Bioequivalence Study of Generic Acyclovir Compared with the Brand Name Acyclovi.-เน€เธ˜ยŽ Noppamas Rojanasthien, M.D-Supanimit Teekachunhatean, M.D Boonyium Kumsorn, M.S Nuchanart Chaichana, M.S
Hay YK Mail

The bioequivalence study of 200-mg generic acyclovir was conducted in healthy males. The
reference ZoviraxเธŽ and the test ZevinเธŽ 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 pharma-
cokinetic parameters were analyzed by non-compartmental analysis.
Results : The t
112
for the test (4.5
เธ‘
2.4 h) and ZoviraxเธŽ (3.9
เธ‘
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 ZoviraxเธŽ. 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 ZevinเธŽ and ZoviraxเธŽ were bioequivalence.
Key word : Acyclovir, Bioequivalence, ZevinเธŽ, ZoviraxเธŽ

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