drugset / Trial / NCT01304069

Effect of Celecoxib and Etoricoxib on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol

NCT01304069

Phase 1 Completed 12 enrolled Turku University Hospital
RandomizedCrossoverSingle-blindBasic science

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 selecoxib and etoricoxib. Selecoxib 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.

Timeline

Start
2011-01
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 200 mg Oral
Comparator Etoricoxib Small molecule 120 mg Oral

Indications

No indication recorded.