Status:
COMPLETED
Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University Bundang Hospital
Conditions:
Healthy
Eligibility:
All Genders
20-40 years
Phase:
PHASE1
Brief Summary
To evaluate the corrected QT interval change(automatic-reading) after single oral administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean Adults.
Detailed Description
Randomized, Open-label, Placebo-controlled, 4-way crossover study
Eligibility Criteria
Inclusion
- Healthy subjects aged 20 - 40 years.
- A body weight in the range of 50 kg (inclusive) - 90 kg (inclusive) and a body mass index (BMI) in the range 19.0 kg/m2 (inclusive) - 25.0 kg/m2 (inclusive).
- Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
Exclusion
- Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Escitalopram, Quetiapine, Moxifloxacin)) or other quinolone group antibiotics.
- Subject judged not eligible for study participation by investigator.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01871701
Start Date
November 1 2012
End Date
May 1 2014
Last Update
June 3 2014
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam, Gyounggi, South Korea