2006•Medical Journal of National Defending Forces in North ChinaRequires access
Study on Bioequivalence of Omeprazole Enteric-coated Capsules in Healthy Volunteers
Hou Yan-ning
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Abstract
Objective:To evaluate the bioequivalence of omeprazole enteric-coated capsule and reference capsule in healthy volunteers.Methods:In a randomized crossover study,22 healthy male volunteers were given a single oral dose of 40 mg test capsules and reference capsules.The concentration of omeprazole in plasma was determined by a RP-HPLC method.Results:After administration of reference capsules and test capsules,the pharmacokinetic parameters were as follows: c_(max)were(0.93±0.57)and(0.98±0.52)μg/ml,respectively;t_(max)were(2.36±0.90)and(2.30±1.04)h,t_(1/2) were(1.18±0.46)and(1.15±0.57)h;AUC_(0~8h)were(2.48±2.09)and(2.48±1.98)μg·h·ml~(-1),AUC_(0~∞) were(2.65±2.39)and(2.65±2.28)μg·h·ml~(-1),respectively.The relative bioavailability of omeprazole enteric-coated capsules was(111.1±58.1)%.Conclusion:The two preparations were bioequivalent.