A bioequivalence study of the cefuroxime axetil in healthy volunteers
Rojanasthien, N.; Boonchaliew, C.; Kumsorn, B.; Sangdee, C.
Journal of the Medical Association of Thailand 86(11): 1063-1072
2003
ISSN/ISBN: 0125-2208 PMID: 14696789 Document Number: 8086
The bioequivalence of 250-mg cefuroxime axetil was evaluated; Furoxime (by the Siam Bheasach Company, Thailand) as the test and Zinnat (GlaxoWellcome) as the reference. The two products were administered as a single dose according to a two-way crossover design, 1-week washout period to 12 healthy Thai male volunteers. Thereafter, serial blood samples were collected over a period of 15 hours. Plasma cefuroxime concentrations were measured by HPLC. The pharmacokinetic parameters were analyzed by noncompartmental analysis. The Tmax [median (range, h)] of Furoxime and Zinnat were 1.5 (1.0-3.0) and 1.75 (1.0-3.5), respectively. The Tmax of Furoxime was faster than Zinnat with the mean (90% CI) of difference in Tmax of -0.5 [(-1.01)-0.01] h. Bioequivalence analysis showed that the AUC(0-infinity) and the Cmax of the two products were not significantly different. The point estimator (90% CI) for the ratio [Furoxime/Zinnat] of log transformed data of the AUC(0-infinity) and Cmax were 1.03 (0.98-1.20) and 1.09 (1.02-1.24), respectively and were within the bioequivalence range of 0.80-1.25.
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