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Effects of Three Single Oral Doses of Trazodone on the QTc Interval Duration in Healthy Volunteers

NCT03516630 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-31

No results posted yet for this study

Summary

The present study has been designed to evaluate the effect of three doses of trazodone (20, 60 and 140 mg), in comparison to placebo, on the QT/QTc interval of healthy volunteers. Trazodone oral drops 6% formulation has been selected in order to evaluate the three doses using the same formulation, because the lowest available strength for the tablet formulations is 50 mg. According to the E14 guideline on the evaluation of QT/QTc interval prolongation and proarrhythmic potential of antiarrhytmic drugs, a negative control (placebo) and a positive control (moxifloxacin) will also be assessed.

Conditions

  • Healthy

Interventions

DRUG

Trazodone 20 mg

Oral drops

DRUG

Trazodone 60 mg

Oral drops

DRUG

Trazodone 140 mg

Oral drops

DRUG

Placebo

Oral drops

DRUG

Moxifloxacin 400mg

Tablet

Sponsors & Collaborators

  • Cross Research S.A.

    collaborator INDUSTRY

  • eResearch Technology, Inc.

    collaborator INDUSTRY

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2017-05-01
Completion
2017-05-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT03516630 on ClinicalTrials.gov