In healthy volunteers, AUC(infinity) and C(max) of fenofibrate, when administered via sustained-release capsules immediately after the consumption of food, was increased significantly from the fasting conditions (p < 0.01). The greatest AUC(infinity) and C(max) occurred when the capsules were taken after a high-fat breakfast.
Background : The bioavailability of a generic preparation of aceclofenac (Omenol from Korea United Pharmaceutical Company) was evaluated in comparison with a proprietary product (Losec from Astra Pharmaceutical Company).Methods : Sixteen healthy male volunteers participated in the study conducted according to a two-way crossover, open-labeled Latin square design. The bioavailability was compared using the parameters total area under the plasma concentration-time curve (AUC0-∞ ), peak plasma concentration (Cmax) and time to reach peak plasma concentration (Tmax) Results : No statiscally significant difference was observed between the values of the two products in all three parameters. The difference of mean of AUC0-∞ and Cmax values of Omenol over those of Losec was found to lie between 8.05% and 2.49%, respectively, being within the acceptable bioequivalence limit of 20%.Conclusion : These findings indicate that the two preparations are comparable in the extent and rate of absorption.
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