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Completed

NCT Number: NCT02122939

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

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

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Key information

Conditions

Healthy

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seongnam, Gyounggi, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

Primary outcomes

  1. Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F

    Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 32, 48 h post-dose

Secondary outcomes

  1. QTc interval

    Time frame: pre-dose, 1, 4, 6, 8, 12, 24, 28, 32, 48 h post-dose

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

An Open-label, Single Dosing Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram After Oral Administration in Elderly Volunteers

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2014
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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