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

University of Southern Denmark (SDU)

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: placebo and tramadol; Drug: placebo; Drug: escitalopram and tramadol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00692263

EudraCT: 2007-004470-10

AKF-372

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 3 patient groups

A

Experimental group

Description:

Escitalopram - tramadol

Treatment:

Drug: escitalopram and tramadol

B

Experimental group

Description:

Placebo - tramadol

Treatment:

Drug: placebo and tramadol

C

Experimental group

Description:

placebo - placebo

Treatment:

Drug: placebo