Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 95 of 482 for:    ESCITALOPRAM AND Antagonists

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02122939
Recruitment Status : Completed
First Posted : April 25, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Jae Yong Chung, Seoul National University Bundang 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Escitalopram Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Escitalopram Drug: Escitalopram



Primary Outcome Measures :
  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 Outcome Measures :
  1. QTc interval [ Time Frame: pre-dose, 1, 4, 6, 8, 12, 24, 28, 32, 48 h post-dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122939


Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyounggi, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jae-Yong Chung, MD, PhD Seoul National University Bundang Hospital, Seongnam, Korea

Layout table for additonal information
Responsible Party: Jae Yong Chung, Associate professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02122939     History of Changes
Other Study ID Numbers: ECTE
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Citalopram
Dexetimide
Muscarinic Antagonists
Cholinergic Antagonists
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Cholinergic Agents