Comparative bioavailability study of cefixime administered as tablets or aqueous solution.
The relative bioavailability of cefixime was studied in 24 healthy male volunteers, with each subject receiving a single 400mg dose of cefixime administered as an aqueous solution, a 400mg tablet and two 200mg tablets, in a randomised crossover sequence. Serum and urine samples were analysed using high-performance liquid chromatography. Peak cefixime levels were achieved 3 hours after administration of the solution vs 4 hours for the 2 tablet formulations; however, the extent of absorption was only slightly improved with the solution (by 14 and 7% compared with the 1 x 400 and 2 x 200mg tablets, respectively). The 400mg and 2 x 200mg tablets were found to be bioequivalent. The pharmacokinetic profile of the 400mg cefixime tablet (mean maximum plasma concentrations of 4.4 mg/L at 4 hours, area under the concentration-time curve of 34.4 mg/L.h, and apparent terminal elimination half-life of 3.7 hours) supports the clinical evaluation of a 400mg once-daily dosage regimen for cefixime.
Montay
G
G
Rhône-Poulenc Rorer, Antony, France.
Masala
F
F
Le Roux
Y
Y
Le Liboux
A
A
Uhlrich
J
J
Chassard
D
D
Thebault
J J
JJ
Roche
G
G
Frydman
A
A
D000328:Adult; D001682:Biological Availability; D020682:Cefixime; D002439:Cefotaxime / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D008297:Male; D012996:Solutions; D013607:Tablets
D012996:Solutions; D013607:Tablets; D020682:Cefixime; D002439:Cefotaxime