Official Title: “The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• 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
• Drug: placebo
  • placebo identical for 10 mg/ 20 mg escitalopram and 150 mg 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Escitalopram - tramadol
• Experimental: B
  • Placebo - tramadol
• Experimental: C
  • placebo - placebo

Primary Measures

• AUC of (+)-M1 metabolite of tramadol
  • Time Frame: 24 hours
    Safety Issue?: No

Secondary Measures

• Dynamic pupillometry
  • Time Frame: 24 hours
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• Alcohol or drug abuse

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Southern Denmark

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00692263

Study ID Number: AKF-372

ClinicalTrials.gov Identifier: NCT00692263

Health Authority: Denmark: Danish Dataprotection Agency