A Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram in Elderly Volunteers

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT02122939

ECTE

Details and patient eligibility

About

An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the effect on ECG of escitalopram after oral administration in elderly volunteers.

Enrollment: 12 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy subject aged 65 or older at screening
• A body weight in the range of 50 kg (inclusive) to 90 kg (inclusive) with BMI range of 19.0 to 28.0
• subjects who decide to participate voluntarily and write a informed consent form

Exclusion criteria

• subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
• Subject judged not eligible for study participation by investigator

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Escitalopram

Experimental group

Treatment:

Drug: Escitalopram