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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00692263

Enrollment

Registered

2008-06-06

Start date

2008-02-29

Completion date

2008-08-31

Last updated

2008-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy subjects

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

Interventions

DRUGescitalopram and tramadol

10 mg escitalopram for 3 days 20 mg escitalopram for 6 days 150 mg tramadol as a single dose on day 9

DRUGplacebo

placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol

DRUGplacebo and tramadol

9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Alcohol or drug abuse

Design outcomes

Primary

Measure	Time frame
AUC of (+)-M1 metabolite of tramadol	24 hours

Secondary

Measure	Time frame
Dynamic pupillometry	24 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026