Zeitschrift für Bioäquivalenz und Bioverfügbarkeit

Abstrakt

600 mg Oxcarbazepine Tablets Bioequivalence Study

Vargas M and Villarraga EA

Bioequivalence studies are evidence of generic drugs quality, demonstrating that the rate and quantity of effective substance absorbed from each of the studied formulations, showed no significant differences. The aim of the pharmacokinetic study of the two formulations, containing 600 mg of Oxcarbazepine, is to analyse bioavailability between the Test Product (Oxicodal® from Synthesis Laboratory S.A.S, Colombia) and the Reference Product (Trileptal® from Novartis Laboratory) and to affirm the Bioequivalence. Therefore, a study was developed in 24 healthy volunteers; an open, four periods and four randomized sequences, with one dose of 600 mg during fasting and postprandial conditions, and 7-day wash time between each period study. Conducting the study in 4 periods obeys the need to know if there are differences in relation to the presence or not of food during the bioavailability of the formulations studied. The benefits sought in this study are to offer public health a guarantee of quality, safety and inter-changeability of the drugs studied to increase the population's access to generic medicines.

The analytical method used was HPLC chromatography UV detector. The 90% confidence interval for the parameters Cmax, AUC0-t and AUC0-∞, according to European guidelines and the FDA is within the permitted ranges for the declaration of bioequivalence and compatibility of the Synthesis S.A.S (Colombia) product Oxicodal®, with the Novartis Laboratories Reference Product Trileptal®, for both feeding conditions, fasting and postprandial.