Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00692263
First received: June 3, 2008
Last updated: September 9, 2008
Last verified: September 2008

June 3, 2008
September 9, 2008
February 2008
August 2008   (final data collection date for primary outcome measure)
AUC of (+)-M1 metabolite of tramadol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00692263 on ClinicalTrials.gov Archive Site
Dynamic pupillometry [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: 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
    Other Names:
    • Lexapro
    • Ultram
  • Drug: placebo
    placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol
    Other Name: placebo
  • Drug: placebo and tramadol
    9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9
    Other Names:
    • placebo
    • Ultram
  • Experimental: A
    Escitalopram - tramadol
    Intervention: Drug: escitalopram and tramadol
  • Experimental: B
    Placebo - tramadol
    Intervention: Drug: placebo and tramadol
  • Experimental: C
    placebo - placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Alcohol or drug abuse
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00692263
AKF-372, EudraCT: 2007-004470-10
Yes
Professor, M.D. Kim Brosen, Institute of Pyblic Health, Clinical Pharmacology, University of Soutern Denmark
University of Southern Denmark
H. Lundbeck A/S
Study Chair: Kim Brosen, MD, D.Sc Institute of Public Healht, Clinical Pharmacology, University of Southern Denmark
University of Southern Denmark
September 2008

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