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

NCT ID: NCT00692263

Last Updated: 2008-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Healthy

Keywords

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Healthy subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Escitalopram - tramadol

Group Type EXPERIMENTAL

escitalopram and tramadol

Intervention Type DRUG

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

B

Placebo - tramadol

Group Type EXPERIMENTAL

placebo and tramadol

Intervention Type DRUG

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

C

placebo - placebo

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

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

Interventions

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escitalopram and tramadol

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

placebo and tramadol

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

Intervention Type DRUG

Other Intervention Names

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Lexapro Ultram placebo Ultram

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Alcohol or drug abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Institute of Pyblic Health, Clinical Pharmacology, University of Soutern Denmark

Principal Investigators

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Kim Brosen, MD, D.Sc

Role: STUDY_CHAIR

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

Locations

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

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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EudraCT: 2007-004470-10

Identifier Type: -

Identifier Source: secondary_id

AKF-372

Identifier Type: -

Identifier Source: org_study_id