Bioequivalence study of generic acyclovir compared with the brand name acyclovir.
The 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 1 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 t 1/2 for the test (4.5 +/- 2.4 h) and Zoviraxl (3.9 +/- 2.6 h) were comparable. The analysis of variance was carried out and the median Tmax (1.50 h) for the test was not statistically difference from Zovirax. The mean (90% CI) of the AUC0-infinity and the Cmax ratios for (Test/reference) 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.
Rojanasthien
Noppamas
N
Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.
Teekachunhatean
Supanimit
S
Kumsorn
Boonyium
B
Chaichana
Nuchanart
N
Hay
Yuen Kah
YK
D000212:Acyclovir / Q000097:blood / Q000493:pharmacokinetics*; D000328:Adult; D000998:Antiviral Agents / Q000097:blood / Q000493:pharmacokinetics*; D016568:Drugs, Generic / Q000032:analysis / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013810:Therapeutic Equivalency
D000998:Antiviral Agents; D016568:Drugs, Generic; D000212:Acyclovir