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

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ClinicalTrials.gov Identifier: NCT00692263
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : September 10, 2008
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
University of Southern Denmark

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Drug: escitalopram and tramadol Drug: placebo Drug: placebo and tramadol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
Study Start Date : February 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. AUC of (+)-M1 metabolite of tramadol [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Dynamic pupillometry [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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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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): NCT00692263


Locations
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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
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Study Chair: Kim Brosen, MD, D.Sc Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark
More Information
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Responsible Party: Professor, M.D. Kim Brosen, Institute of Pyblic Health, Clinical Pharmacology, University of Soutern Denmark
ClinicalTrials.gov Identifier: NCT00692263    
Other Study ID Numbers: AKF-372
EudraCT: 2007-004470-10
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: September 10, 2008
Last Verified: September 2008
Keywords provided by University of Southern Denmark:
Healthy subjects
Additional relevant MeSH terms:
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Tramadol
Citalopram
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
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents