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Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers

NCT00839072 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-04-27

Study results available
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Summary

The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations

Conditions

  • Healthy

Interventions

DRUG

Trazodone HCl

100 mg immediate-release tablet, dosing q8h

DRUG

Trazodone HCl

300 mg extended-release caplet, single dose

Sponsors & Collaborators

  • Algorithme Pharma Inc

    collaborator INDUSTRY

  • Labopharm Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, MD · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-02-28
Completion
2009-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00839072 on ClinicalTrials.gov