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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Seoul National University Bundang Hospital
• Treatments: Citalopram; Dexetimide; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Psychotropic Drugs; Quetiapine Fumarate

Criteria

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.