At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 24 enrolled

Drug / intervention

Trazodone HCl +3 moredrug

Likely dose

Trazodone HCl 300 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01121913

NCT01121913Phase 1Completed

Compare CT.gov

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

Labopharm Inc.·interventional·Posted May 12, 2010·Updated Apr 27, 2012

In Brief

A Phase 1 clinical trial evaluating Trazodone HCl for Healthy. Completed, enrolled 24 participants.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy

Countries--

Collaborators--

Timeline

Phase 1CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2005

Primary CompletionApr 2005

First PostedMay 2010

TodayJul 2026

First PostedMay 12, 2010

Enrollment StartMar 1, 2005

Primary CompletionApr 1, 2005

TodayJul 2, 2026

Enrollment to primary: 1 monthPosted 16.1 years ago

Interventions

Trazodone HCldrug

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.

Trazodone HCldrug

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.

Trazodone HCldrug

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.

Trazodone HCldrug

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.