Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers

The objectives of this study were: * to compare the pharmacokinetic profiles of two prototype controlled-release (CR) trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under fasting condition; * to assess the controlled release properties of the two prototype formulations; * to select a prototype formulation for further development; * to validate the blood sampling schedule for future pivotal pharmacokinetic studies; * to determine the appropriate sample size for pivotal studies based in the intra-subject variability.