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
  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:


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
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
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
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

No publications provided

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:
Dexetimide
Citalopram
Tramadol
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 16, 2014