A bioequivalence study of the cefuroxime axetil in healthy volunteers.
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.


RESULTS
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.
Rojanasthien
Noppamas
N
Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.
Boonchaliew
Chayanontchaimongkol
C
Kumsorn
Boonyium
B
Sangdee
Chaichan
C
D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D001682:Biological Availability; D002444:Cefuroxime / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D011336:Probability; D012016:Reference Values; D013810:Therapeutic Equivalency
D002444:Cefuroxime; C040738:cefuroxime axetil