Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers

Abstract

This is a pharmacokinetic study of two formulations containing Lurasidone 80 mg, with the aim to compare the Bioavailability between the Test product (Lurasidone made by Laboratorios Lafrancol S.A, Colombia) and the Reference product (Latuda® made by Laboratorio Sunovion) in order to declare the Bioequivalence between both formulations. For this, an open-label, two period and two sequences previously randomized, crossover study in 24 healthy volunteers was developed, with a single 80 mg dose in fasting conditions, a washout period of 15 days and 12 plasma samples collection between 0 and 72 h. The analytical method used was HPLC. The 90% confidence interval for the Cmax parameter was between 96.4–103.7 with a 103.2 ratio; for the AUC0-t parameter the 90% CI it is between 86.8-107.4 with a 98.2 ratio, and for the AUC0-∞ the 90% CI was found to be between 90.4–108.9 with a 99.2 ratio. According to the European and FDA guidelines for Bioequivalence research, the confidence interval is within the allowed ranges for the Bioequivalence declaration and interchangeability of the Lafrancol S.A. product with the Reference product.