The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
Information source: University of Southern Denmark
Information obtained from ClinicalTrials.gov on August 08, 2008
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: Recruiting
Sponsored by: University of Southern Denmark
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
Clinical Details
Official title: The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: AUC of (+)-M1 metabolite of tramadol
Secondary outcome: Dynamic pupillometry
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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; Recruiting
Lene Noehr-Jensen, MHSc, Phone: 45-6550-3005, Email: lnjensen@health.sfu.dk
Lene Noehr-Jensen, MHSc., Sub-Investigator
Kim Brosen, M.D., Principal Investigator
Additional Information
Starting date: February 2008
Ending date: August 2008
Last updated: July 3, 2008
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