Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01871701

Enrollment

Registered

2013-06-07

Start date

2012-11-30

Completion date

2014-05-31

Last updated

2014-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Corrected QT interval prolongation, Psychotropic drugs

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

Interventions

DRUGEscitalopram

Escitalopram

DRUGQuetiapine

Quetiapine

DRUGMoxifloxacin

Moxifloxacin

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy subjects aged 20 - 40 years. 2. 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). 3. 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

1. Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Escitalopram, Quetiapine, Moxifloxacin)) or other quinolone group antibiotics. 2. Subject judged not eligible for study participation by investigator.

Design outcomes

Primary

Measure	Time frame
Corrected QT interval prolongation	Predose (3 times) and 1, 2, 3, 4, 6, 8, 12, 16, 24 h, additional 26, 28, 32, 48 h after escitalopram dosing

Secondary

Measure	Time frame	Description
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, Cmax, Tmax, t1/2, CL/F
AUC (area under the plasma concentration-time curve)of quetiapine, moxifloxacin	Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose	AUC, Cmax, Tmax, t1/2, CL/F

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026