NCT01443520

Effect of Duloxetine and Venlafaxine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol: A Three-phase Randomized Balanced Cross-over Study in Healthy Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Tramadol is an opioid analgesic, which is widely used in the treatment of acute and neuropathic pain. After oral administration, tramadol is rapidly and almost completely absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral tramadol with duloxetine and venlafaxine. Duloxetine is known to inhibit CYP2D6. Twelve healthy male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of the ideal weight for height are taken into the study. Primary endpoints of the study are plasma concentrations of tramadol and its metabolites.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo	The subjects will be given orally placebo twice a day for 8 days prior to the study.
DRUG	Duloxetine	The subjects will be given orally duloxetine 30mg twice a day for 8 days prior to the study.
DRUG	Venlafaxine	The subjects will be given orally venlafaxine 37,5mg twice a day for 8 days prior to the study.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-09-29
• Last updated: 2012-05-22

Locations

1 site across 1 country: Finland