Who is sponsoring NCT01214941?

NCT01214941 is sponsored by Turku University Hospital.

What condition does NCT01214941 study?

NCT01214941 studies Pharmacokinetics, Pharmacodynamics.

What drugs are being tested in NCT01214941?

Interventions: Placebo, Ticlopidine, Ticlopidine and itraconazole.

What is the status of NCT01214941?

NCT01214941 is currently COMPLETED.

Last reviewed 2011-04-12 · How we verify

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

NCT01214941 Phase 4 COMPLETED

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.

Details

Lead sponsor	Turku University Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	12
Start date	2010-09
Completion	2010-12

Conditions

Pharmacokinetics
Pharmacodynamics

Interventions

Placebo
Ticlopidine
Ticlopidine and itraconazole

Primary outcomes

Concentration of tramadol and its metabolites in plasma — 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours after administration of tramadol

Countries

Finland