NCT01214941

Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol

• 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. The formation of inactive metabolites is catalysed by CYP3A4 and 2B6. This study is aimed to investigate the possible interaction of oral tramadol with itraconazole and ticlopidine, which are inhibitors of CYP3A4 and 2B6. 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

• Pharmacokinetics
• Pharmacodynamics

Interventions

Type	Name	Description
DRUG	Placebo	The subjects will be given orally placebo twice a day for 5 days prior to the study.
DRUG	Ticlopidine	The subjects will be given orally ticlopidine 250mg twice a day for 5 days prior to the study.
DRUG	Ticlopidine and itraconazole	The subjects will be given orally ticlopidine 250mg twice a day and itraconazole 200mg as a single daily dose for 5 days prior to the study.

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-10-05
• Last updated: 2011-04-13

Locations

1 site across 1 country: Finland