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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: escitalopram and tramadol; Drug: placebo and tramadol; Drug: placebo

• Registration Number: NCT00692263
• Lead Sponsor: University of Southern Denmark

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-09
• Last Update Posted: 2008-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• Alcohol or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	escitalopram and tramadol	Escitalopram - tramadol
B	placebo and tramadol	Placebo - tramadol
C	placebo	placebo - placebo

Primary Outcome Measures

Name	Time	Method
AUC of (+)-M1 metabolite of tramadol	24 hours

Secondary Outcome Measures

Name	Time	Method
Dynamic pupillometry	24 hours

Trial Locations

Locations (1)

Institute of Public Health, Clinical Pharmacology, University of Southern Denmark; 🇩🇰 Odense, Denmark