Determination of Bioequivalence of Cefixime by Three-way Crossover Design
- VernacularTitle:三交叉试验设计考察头孢克肟不同制剂生物等效性
- Author:
Aixin SHI
;
Yufei FENG
;
Kexin LI
;
Lei LIU
;
Qi YIN
;
Chunhua SUN
- Publication Type:Journal Article
- Keywords:
Cefixime;
Bioequivalence;
Three-way crossover
- From:
China Pharmacy
1991;0(02):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the bioequivalence of suspension formulation of cefixime(A),capsule formulation of ce-fixime(B) and reference preparation(C: Cefixime Capsules or Cefspan) in human body.METHODS: The study was conducted as a 3- way crossover design in 18 healthy volunteers whose plasma concentrations of cefixime were determined by HPLC after receiving a single oral dose of 200 mg trial preparations or reference preparation.RESULTS:The main pharmacokinetics of the three preparations(A、B、C) were as follows after undergoing BIO3 program fitting:AUC0-1 were(18.54?6.31)mg?h-1?L-1, (16.10?5.51)mg?h-1?L-1 and (17.16?5.96)mg?h-1?L-1, Cmax were(2.63?0.76) mg?L-1, (2.43?0.78)mg?L-1 and (2.57?0.90)mg?L-1;tmax were(4.11?0.58)h,(4.56?0.51)h and (4.56?0.70)h,respectively .The relative bioavailability of cefixime suspensions(A) and cefixime capsules(B) were (108.8?12.3)% and (95.7?15.9)% ,respectively as against reference preparation(C) .CONCLUSION:The test formulations(A and B) were found bioequivalent to the reference formulation(C).
