"Effekten af escitalopram på tramdadols farmakokinetik og farmakodynamik"

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004470-10-DK

Enrollment

Registered

2007-12-06

Start date

2008-01-28

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: Cipralex 10 mg Pharmaceutical Form: Tablet INN or Proposed INN: escitalopram Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Any clinical or paraclinical significant fidings, Drug or alcohol abuse, known allergy towards escitalopram or tramadol

Design outcomes

Primary

Measure	Time frame
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)	—

Countries

Denmark

Outcome results