Drug-Food Interaction Study of Seville Orange Juice and Colchicine
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one
of the enzymes responsible for the metabolism of colchicine. This study will evaluate the
effect of multiple daily consumptions of Seville orange juice on the pharmacokinetic profile
of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and
tolerability of this regimen in healthy volunteers. All study subjects will be monitored for
adverse events throughout the study period.