Effects of Three Single Oral Doses of Trazodone on the QTc Interval Duration in Healthy Volunteers
Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborators:
Cross Research S.A. eResearch Technology, Inc.
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination Trazodone