A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
Grapefruit juice is an inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the
enzyme systems responsible for the metabolism of colchicine. This study will evaluate the
effect of multiple daily consumptions of grapefruit 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.