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OpenTrials
Completed

NCT Number: NCT00692263

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Public Health, Clinical Pharmacology, University of Southern Denmark

Odense, DK-5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Alcohol or drug abuse

Treatment and study plan

escitalopram and tramadol

Drug

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

Other names: Lexapro, Ultram

Placebo

Drug

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

placebo and tramadol

Drug

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

Other names: placebo, Ultram

Primary outcomes

  1. AUC of (+)-M1 metabolite of tramadol

    Time frame: 24 hours

Secondary outcomes

  1. Dynamic pupillometry

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 6, 2008
Registry last updated
Sep 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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