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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-05-31

Brief Summary

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To evaluate the corrected QT interval change(automatic-reading) after single oral administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean Adults.

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Detailed Description

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Randomized, Open-label, Placebo-controlled, 4-way crossover study

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quetiapine

Quetiapine 100 mg (Seroquel, Tablet)

Group Type EXPERIMENTAL

Quetiapine

Intervention Type DRUG

Quetiapine

Moxifloxacin

Moxifloxacin 400 mg (Avelox, Tablet)

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

Moxifloxacin

Escitalopram

Escitalopram 20 mg (Lexapro, Tablet)

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Escitalopram

Placebo

Water intake

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Escitalopram

Intervention Type DRUG

Quetiapine

Intervention Type DRUG

Moxifloxacin

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Escitalopram 20 mg (Lexapro, Tablet) Quetiapine 100 mg (Seroquel, Tablet) Moxifloxacin 400 mg (Avelox, Tablet) Water intake

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes