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Cefamandole is one of the second-generation cephalosporins. The
bioequivalent study of cefamandole formulations manufactured by
two different pharmaceutical companies (Cefadol, U-Liang, lot
No.: U9811; Mandol, Lilly, lot No.: A4037A) was carried out. A
single 500mg dose of Cefadol or Mandol was administered in 24
healthy Chinese males by a 2 X 2 cross-over design with one
week washout period between each dose. Plasm samples were
collected before dosing and at the time of 0.25, 0.5, 0.75, 1,
1.5, 2, 2.5 , 3, 4, 6, and 8 hours after dosing. The plasm
concentrations were analyzed by HPLC. The area under the plasm
concentration- time curve (AUCinf), the area under the curve
only to the time of the lase quantifiable concentration
(AUClqc), the peak con- centration (Cmax), the ratio of Cmax/
AUClqc, the ratio of Cmax/ AUCinf, and the time to peak
concentration (Tmax) were compared by parametric and
nonparametric method. The results showed no significant
difference between Cefadol and Mandol. The statis- tical power
to detect 20% difference was larger than 0.99. The average
plasma concentrations of cefamandole at each point of the two
products were not significantly different. The cefama- ndole
plasma concentrations were fitted with one compartment modol
assuming first order absorption and with lag time by PCNONLIN
program. We concluded that Cefadol and Mandol are bioequivalent.
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