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

Tracking Information

First Received Date ^ICMJE

June 3, 2008

Last Updated Date

September 9, 2008

Start Date ^ICMJE

February 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

AUC of (+)-M1 metabolite of tramadol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00692263 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Dynamic pupillometry [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: escitalopram and tramadol
Drug: placebo
Drug: placebo and tramadol

Study Arms / Comparison Groups

Experimental: Escitalopram - tramadol
Experimental: Placebo - tramadol
Experimental: placebo - placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Alcohol or drug abuse

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00692263

Responsible Party

Professor, M.D. Kim Brosen, Institute of Pyblic Health, Clinical Pharmacology, University of Soutern Denmark

Study ID Numbers ^ICMJE

AKF-372, EudraCT: 2007-004470-10

Study Sponsor ^ICMJE

University of Southern Denmark

Collaborators ^ICMJE

H. Lundbeck A/S

Investigators ^ICMJE

Study Chair:

Kim Brosen, MD, D.Sc

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

Information Provided By

University of Southern Denmark

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP