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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692263
• Other study ID #: AKF-372
• Secondary ID: EudraCT: 2007-00
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2008
• Last updated: September 9, 2008
• Start date: February 2008
• Est. completion date: August 2008

Study information

• Verified date: September 2008
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy

• Age: 18 - 45 years

• CYP2D6 phenotyped as extensive metabolizer

• CYP2C19 phenotyped as extensive metabolizer

Exclusion Criteria:

• Alcohol or drug abuse

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Denmark	Institute of Public Health, Clinical Pharmacology, University of Southern Denmark	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	H. Lundbeck A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of (+)-M1 metabolite of tramadol		24 hours	No
Secondary	Dynamic pupillometry		24 hours	No