Bioequivalence of ornidazole tablets in Chinese healthyvolunteers

Objective To assess the pharmacokinetics and bioequivalence of test and domestic marketed ornidazole tablets in healthy volunteers.Methods A single dose of 1500 mg ornidazole was orally given to 22 healthy volunteers in a randomized cross-over study.The concentrations of ornidazole in plasma was determined by high performance liquid chromatography(HPLC).The pharmacokinetic parameters were calculated by DAS.Results The main pharmacokinetic parameters were as follows: t1/2 were(13.69±3.20) h and(14.31±4.30) h,tmax were(1.89±1.26) h and(1.73 ±1.10) h,Cmax were(29.13±3.57)μg·mL-1 and(28.22±4.19)μg·mL-1,AUC0-t were(619.3±98.9) μg·h·mL-1 and(601.1±92.9)μg·h·mL-1,AUC0-∞ were(626.4±102.0)μg·h·mL-1 and(609.0±94.3)μg·h·mL-1,respectively.The relative bioavailability were(103.4±10.1)% for AUC0-t and(103.2±10.1)% for AUC0-∞,respectively.Conclusion The test and reference preparations were bioequivalent.Both preparations were well tolerated.