Effekten af escitalopram på tramdadols farmakokinetik og farmakodynamik
- Registration Number
- EUCTR2007-004470-10-DK
- Lead Sponsor
- Institut for Sundhedstjenesteforskning, Klinisk Farmakologi, Syddansk Universitet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Healthy volounteers, written informed consent, age 18-45 years, fenotyped as CYP2C19 and CYP2D6 extensive metabolizers
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Any clinical or paraclinical significant fidings, Drug or alcohol abuse, known allergy towards escitalopram or tramadol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of escitalopram on tramadol metabolism, measures as tramadol pharmacokinetics;Secondary Objective: To investigate the effect of escitalopram on tramadol pharmakodynamics, measured as static and dynamic pupil measuments, Cold Pressor Test and Critical Flicker Fusion Test;Primary end point(s): AUC of (+)-M1 (metabolite of tramadol)
- Secondary Outcome Measures
Name Time Method