CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 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/NCT01121900
NCT01121900Phase 1Completed
CompareCT.gov

A Randomized, Two-way Crossover Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets (Containing Contramid®) (Administered as a Single Dose) and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily) Under Fasting Conditions

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 26 participants.

Detailed Summary

The objective of this study was to compare the pharmacokinetic profiles of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered as a single dose, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp), when administered three times daily. For this purpose the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of the two formulations, were compared under fasting conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 12, 2010
Enrollment StartJun 1, 2008
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.1 years ago

Interventions

Trazodone HCldrug

Dosage form: Extended-release caplets containing 300 mg trazodone HCl Dose: 300 mg trazodone HCl extended-release caplets (one caplet) at 23:30 on Day 1 of the test product treatment period following a fasting period of at least 4 hours.

Trazodone HCldrug

Dosage form: Immediate-release tablets containing 100 mg trazodone HCl Dose: 100 mg trazodone HCl immediate-release tablets (one tablet per dosing time) at 23:30 on Day 1, at 07:30 and 15:30 on Day 2 of the reference product treatment period.