Status:
UNKNOWN
Paroxetines Effect on Tramadols Metabolism and Pharmakodynamics: a Dose Response Study
Lead Sponsor:
University of Southern Denmark
Conditions:
Depression
Pain
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to examine the connection between the dose of paroxetine and the effect of paroxetine on tramadols metabolism and thereby the effect of tramadol on the median pupil size. ...
Detailed Description
The purpose of the study is to examine the connection between the dose of paroxetine and the effect of paroxetine on tramadols metabolism and thereby the effect of tramadol on the median pupil size. ...
Eligibility Criteria
Inclusion
- Healthy volunteers judged from the medical anamnesis and examination, inclusive a laboratory examination.
- Signed written approval and authorization, witch give relevant people (the GCP-unit, the the Danish Medicines Agency and the ethics committee of Southern Denmark) access to documents and data of interest to this study
- Age: 18 - 45 years
- Women must use one of the Danish Medicines Agency defined safe contraception. A negative pregnancy test has to ensure that the volunteers are not pregnant at the start of the study
- All the volunteers have to be phenotyped as CYP2D6 extensive metabolizer (EM) by a "tramadol test": the volunteer ingest 50 mg tramadol and all urine is collected fore 8 hours. By a HPLC method the metabolic ratio (MR) of (-)-M1/(+)-M1 is determined in the urine. Volunteers with a MR-ratio smaller than 2 is defined as CYP2D6 EM's
Exclusion
- Any clinical significant observation at the medical- or laboratory examination
- Daily use of medicine or alcohol. Periodic use of medicine can be accepted after individual valuation by a doctor
- Allergy or intolerance to paroxetine or tramadol
- Former participation in a clinical study in the last 3 months
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00785603
Start Date
August 1 2008
End Date
February 1 2009
Last Update
February 13 2009
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