Bioequivalence of amoxicillin and clavulanic acid tabletsin healthy volunteers
ZHANG Gui-jun
LI Ke-xin
LIU Lei
SHI Ai-xin
LI Yang
SUN Chun-hua
Abstract：Objective:To study the relative bioequivalence of domest ic and imported amoxicillin and clavulanic acid tablets.Methods:The ra ndomized and crossover study was conducted in 10 healthy male volunteers.After a single dose of the drugs their plasma drug concentration was determined by micr obiological assay.Results:Both the domestic and imported tablets of am oxicillin and clavulanic acid fitted to one compartment model.The pharmacokineti cs parameters obtained were:Cmax=(5.17±0.45)mg/L,Tmax=(1.05±0. 16)h,t1/2=(1.16±0.17)h,AUC0～t=(12.89±1.03)(mg*h)/L for domestic amoxicillin;Cmax=(5.25±0.46)mg/L,Tmax=(1.08±0.23)h,t1/2=(1.3 7±0.23)h,AUC0～t=(13.54±0.59)(mg*h)/L for imported amoxicillin;Cmax =(3.94±0.52)mg/L,Tmax=(1.10±0.21)h,t1/2=(0.98±0.11)h,AUC 0～t=(8.25±0.92)(mg*h)/L for domestic clavulanic acid;Cmax=(4.10±0. 35)mg/L,Tmax=(1.03±0.10)h,t1/2=(1.01±0.14)h,AUC0～t=(8.18± 0.51)(mg*h)/L for imported clavulanic acid.The relative bioequivalence was: (95.3±7.3)% for amoxicillin;(100.6±6.0)% for clavulanic acid.Conclusion:The domestic and imported amoxicillin and clavulanic acid tablets are bioequ ivalence.
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Publication Date：2001-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：3( 105-107 )