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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Escitalopram

• Registration Number: NCT02122939
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-25
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Escitalopram	Escitalopram	-

Primary Outcome Measures

Name	Time	Method
Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F	pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 32, 48 h post-dose

Secondary Outcome Measures

Name	Time	Method
QTc interval	pre-dose, 1, 4, 6, 8, 12, 24, 28, 32, 48 h post-dose

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyounggi, Korea, Republic of