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Clinical Trials/NCT01871701
NCT01871701CompletedPhase 1

Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs in Healthy Korean Adults After a Single Oral Administration of Escitalopram, Quetiapine, and Moxifloxacin

Seoul National University Hospital1 site in 1 country40 target enrollmentStarted: November 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Corrected QT interval prolongation

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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 Criteria

  • 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.

Arms & Interventions

Quetiapine

Experimental

Quetiapine 100 mg (Seroquel, Tablet)

Intervention: Quetiapine (Drug)

Moxifloxacin

Experimental

Moxifloxacin 400 mg (Avelox, Tablet)

Intervention: Moxifloxacin (Drug)

Escitalopram

Experimental

Escitalopram 20 mg (Lexapro, Tablet)

Intervention: Escitalopram (Drug)

Placebo

Placebo Comparator

Water intake

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Corrected QT interval prolongation

Time Frame: Predose (3 times) and 1, 2, 3, 4, 6, 8, 12, 16, 24 h, additional 26, 28, 32, 48 h after escitalopram dosing

Secondary Outcomes

  • AUC (area under the plasma concentration-time curve) of escitalopram(Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48h postdose)
  • AUC (area under the plasma concentration-time curve)of quetiapine, moxifloxacin(Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jae Yong Chung

Assistant Professor

Seoul National University Bundang Hospital

Study Sites (1)

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