To evaluate the bioequivalence of generic omeprazole enteric-coated capsules(20 mg)versus a reference formulation(LOSEC,20 mg)in vivo.Healthy adult subjects were enrolled and randomly and blindly administered with either the generic formulation or the reference formulation of omeprazole enteric-coated capsules.By measuring the concentration of omeprazole in plasma,the bioequivalence of the two formulations was compared using pharmacokinetic parameters and their in vivo safety was evaluated.The results showed that under fasting and postprandial conditions,the geometric mean ratio of pharmacokinetic parameters of the two preparations fell within the acceptance range of bioequivalence,the adverse reactions associated with generic preparation were mild and similar to those of reference formulation,and there were no distinctive differences in safety between the two preparations.
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