A Bioequivalence Study of the Cefuroxime Axetil in Healthy Volunteers

NOPPAMAS ROJANASTHIEN, MD*, CHA YANONTCHAIMONGKOL BOONCHALIEW, BPharm*, BOONYIUM KUMSORN, MS*, CHAICHAN SANGDEE, PhD*.

Affiliation : * Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.

AbstractThe bioequivalence of 250-mg cefuroxime axetil was evaluated; Furoxime® (by the Siam Bheasach Company, Thailand) as the test and Zinnat® (GiaxoWellcome) as the reference. The two pro ducts 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 I 5 hours. Plasma cefuroxime concentrations were measured by HPLC. The pharmacokinetic para meters were analyzed by noncompartmental analysis.
Results : The T max [median (range, h)] of Furoxime® and Zinnat® were 1.5 ( 1.0-3.0) and 1. 75 ( 1.0-3.5), respectively. The T max of Furoxime® was faster than Zinnat# with the mean (90% CI) of difference in T max of -0.5 [( - 1.01 )-0.0 1] h. Bioequivalence analysis showed that the AUC0_~ and the Cmax of the two products were not significantly different. The point estimator (90% CI) for the ratio [Furoxime®fZinnat®] of log transformed data of the AUC0_~ and C"'"' 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.

Keywords : Bioequivalence, Cefuroxime Axetil, Zinnat®, Furoxime®

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