The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects

This study has been completed.

Sponsor:

Collaborator:

H. Lundbeck A/S

Information provided by:

University of Southern Denmark

ClinicalTrials.gov Identifier:

NCT00692263

First received: June 3, 2008

Last updated: September 9, 2008

Last verified: September 2008

History of Changes

Purpose

Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and pharmacodynamic(PD) measurements are done for the next 24 hours.

It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is seen in Pk or PK of tramadol

Condition	Intervention	Phase
Healthy	Drug: escitalopram and tramadol Drug: placebo Drug: placebo and tramadol	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Tramadol Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:

AUC of (+)-M1 metabolite of tramadol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dynamic pupillometry [ Time Frame: 24 hours ] [ Designated as safety issue: No ]


Enrollment:	15
Study Start Date:	February 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Escitalopram - tramadol	Drug: escitalopram and tramadol 10 mg escitalopram for 3 days 20 mg escitalopram for 6 days 150 mg tramadol as a single dose on day 9 Other Names: Lexapro Ultram
Experimental: B Placebo - tramadol	Drug: placebo and tramadol 9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9 Other Names: placebo Ultram
Experimental: C placebo - placebo	Drug: placebo placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy
Age: 18 - 45 years
CYP2D6 phenotyped as extensive metabolizer
CYP2C19 phenotyped as extensive metabolizer

Exclusion Criteria:

Alcohol or drug abuse

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00692263

Locations


Denmark
Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
Odense, Denmark, DK-5000

Sponsors and Collaborators

University of Southern Denmark

H. Lundbeck A/S

Investigators


Study Chair:	Kim Brosen, MD, D.Sc	Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark

More Information


Responsible Party:	Professor, M.D. Kim Brosen, Institute of Pyblic Health, Clinical Pharmacology, University of Soutern Denmark
ClinicalTrials.gov Identifier:	NCT00692263 History of Changes
Other Study ID Numbers:	AKF-372 EudraCT: 2007-004470-10
Study First Received:	June 3, 2008
Last Updated:	September 9, 2008
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Medicines Agency

Keywords provided by University of Southern Denmark:


Healthy subjects

Additional relevant MeSH terms:


Citalopram Dexetimide Tramadol 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 Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Analgesics, Opioid Narcotics Central Nervous System Depressants Analgesics Sensory System Agents

ClinicalTrials.gov processed this record on September 23, 2016

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