Relative Bioavailability and Bioequivalence of Omeprazole Enteric-coated Capsules in Healthy Volunteers

Objective To set up a method of content determination for omeprazole in human plasma by HPLC and study the pharmacokinetics and relative bioavailability of omeprazole enteric-coated capsules. Methods A single dose of reference and test omeprazole enteric-coated capsules was given to 20 healthy volunteers,respectively,in a randomized 2-way cross-over study.The plasma concentration of omeprazole was determined by HPLC and their pharmacokinetics as well as relative bioavailability was measured. Results The main pharmacokinetic parameters of two formulations,reference and test ones were as follows: Cmax were(906.01±589.55)and(875.87±662.95) ng·mL-1,tmax were(2.21±0.88)and(2.07±0.87)h,AUC0-12 were(1 778.70±1 164.11)and(1 834.25±1 342.25)ng·h·mL-1;t1/2 Ke were(0.96±0.25)and(0.85±0.18)h.The relative bioavailability of F0→12 was(104.02 ±13.60)%. Conclusion The two kinds of omeprazole enteric-coated capsules are bioequivalent.