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Original ArticleOpen Access
A Bioequivalence Study of the Cefuroxime Axetil in Healthy Volunteers
Rojanasthien N 
,
Boonchaliew C ,
Kumsorn B ,
Sangdee C
,
Boonchaliew C ,
Kumsorn B ,
Sangdee C The bioequivalence of 250-mg cefuroxime axetil was evaluated; FuroximeเธŽ (by the Siam
Bheasach Company, Thailand) as the test and ZinnatเธŽ (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
FuroximeเธŽ and ZinnatเธŽ were 1.5 ( 1.0-3.0) and 1. 75 ( 1.0-3.5), respectively. The T max of FuroximeเธŽ 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
AUC
0_~
and the Cmax of the two products were not significantly different.
The point estimator (90% CI) for the ratio [FuroximeเธŽfZinnatเธŽ] of log transformed data of the
AUC
0_~
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.
Key word : Bioequivalence, Cefuroxime Axetil, ZinnatเธŽ, FuroximeเธŽ
Bheasach Company, Thailand) as the test and ZinnatเธŽ (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
FuroximeเธŽ and ZinnatเธŽ were 1.5 ( 1.0-3.0) and 1. 75 ( 1.0-3.5), respectively. The T max of FuroximeเธŽ 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
AUC
0_~
and the Cmax of the two products were not significantly different.
The point estimator (90% CI) for the ratio [FuroximeเธŽfZinnatเธŽ] of log transformed data of the
AUC
0_~
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.
Key word : Bioequivalence, Cefuroxime Axetil, ZinnatเธŽ, FuroximeเธŽ
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