600 mg Oxcarbazepine Tablets Bioequivalence Study
- *Corresponding Author:
- Vargas M, D.D.S.,
Unidad de Farmacología Universidad de la Sabana
E-mail: [email protected]
Received Date: June 14, 2017; Accepted Date: July 25, 2017; Published Date: August 04, 2017
Citation: Vargas M, Villarraga EA (2017) 600 mg Oxcarbazepine Tablets Bioequivalence Study. J Bioequiv Availab 9:489-492. doi: 10.4172/jbb.1000350
Copyright: © 2017 Vargas M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.