Paroxetins effekt på tramadols metabolisme og farmakodynamik: et dosis respons studie

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001516-20-DK

Enrollment

Registered

2008-06-12

Start date

2008-06-30

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: Nobligan, kapsler, hårde Pharmaceutical Form: Capsule, hard INN or Proposed INN: tramadol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volounteers, written informed consent, age 18 - 45 years, fenotyped as 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 findings, drug or alcohol abuse, known allergy towards paroxetine or tramadol

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of paroxetine on the metabolism and farmacodynamics of tramadol;Secondary Objective: To investigate the effect of paroxetine on the metabolism and farmacodynamics of tramadol measured as dynamic pupil measuments;Primary end point(s): the dynamic pupil measurement	—

Countries

Denmark

Outcome results