NCT01121913

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

A Randomized, Four-way Crossover Pilot Study to Compare the Relative Bioavailability of Two Prototype Once-a-day Trazodone Hydrochloride Products and Two Marketed Reference Products Following an Equivalent Daily Dose Administration Under Fasting Conditions in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Labopharm Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Trazodone HCl	The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days.
DRUG	Trazodone HCl	The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days.
DRUG	Trazodone HCl	The dosage of trazodone.HCl during this treatment phase was 2 oral doses of 150 mg each: one controlled-release (CR) tablet at 07:30 (after an overnight fast of at least 10 hours) and 19:30 (after a fast of at least 2 hours) on clinic days.
DRUG	Trazodone HCl	The dosage of trazodone.HCl during this treatment phase was three oral doses of 100 mg each: one immediate-release (IR) tablet at 07:30 (after an overnight fast of at least 10 hours), 15:30 and 23:30 (both dosages after a fast of at least 2 hours) on clinic days.

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-04-01
• First posted: 2010-05-12
• Last updated: 2012-04-27
• Results posted: 2010-08-16