At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 30 enrolled

Drug / intervention

Trazodone HCl +1 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/NCT01121926

NCT01121926Phase 1Completed

Compare CT.gov

A Randomized, Two-way Crossover Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets (Containing Contramid®) (Administered Once Daily) and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily) at Steady State

Labopharm Inc.·interventional·Posted May 12, 2010·Updated Apr 30, 2012

In Brief

A Phase 1 clinical trial evaluating Trazodone HCl for Healthy Subjects and 2 related conditions. Completed, enrolled 30 participants.

Detailed Summary

The purpose of this study was to compare the pharmacokinetic profiles at steady state of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp.), when administered three times daily, for one week. For this purpose, the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of each of the two formulations was compared.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy Subjects, Bioavailability, Pharmacokinetics

Countries--

Collaborators--

Timeline

Phase 1CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2008

Primary CompletionMar 2008

First PostedMay 2010

TodayJul 2026

First PostedMay 12, 2010

Enrollment StartJan 1, 2008

Primary CompletionMar 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2 monthsPosted 16.1 years ago

Interventions

Trazodone HCldrug

Dosage form: Extended-release caplets containing 300 mg trazodone HCl and extended-release caplets containing 150 mg trazodone HCl (the 150 mg dosage form was only used for the up and down titration, and was not evaluated in the study). Dose regimen: 75 mg trazodone HCl (½ x 150 mg extended-release caplet) on Days 1 and 11, 150 mg trazodone HCl (one extended-release caplet) on Days 2 and 10, 300 mg trazodone HCl (one extended-release caplet) on Days 3 to 9, each at 23:30 after a fast of at least 4 hours.

Trazodone HCldrug

Dosage form: Immediate-release tablet containing 100 mg trazodone HCl Dose regimen: 100 mg trazodone HCl (one immediate-release tablet) once (at 23:30) on Days 1 and 11, 100 mg trazodone HCl (one immediate-release tablet) twice (at 23:30 and 11:30) on Days 2 and 10, 100 mg trazodone HCl (one immediate-release tablet) three times daily (at 23:30, 07:30 and 15:30) on Days 3 to 9. Evening doses were administered after a fast of at least 4 hours.