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

Information source: University of Southern Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: escitalopram and tramadol (Drug); placebo (Drug); placebo and tramadol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Southern Denmark

Official(s) and/or principal investigator(s):
Kim Brosen, MD, D.Sc, Study Chair, Affiliation: Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: AUC of (+)-M1 metabolite of tramadol

Secondary outcome: Dynamic pupillometry


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


Inclusion Criteria:

- Healthy

- Age: 18 - 45 years

- CYP2D6 phenotyped as extensive metabolizer

- CYP2C19 phenotyped as extensive metabolizer

Exclusion Criteria:

- Alcohol or drug abuse

Locations and Contacts

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

Starting date: February 2008
Last updated: September 9, 2008

Page last updated: August 23, 2015

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