Drug-Drug Interaction Study Between Colchicine and Diltiazem ER
Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
Participant gender:
Summary
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).
Extended-release diltiazem (diltiazem ER) is a potent inhibitor of both CYP3A4 and P-gp. This
study will evaluate the effect of multiple doses of diltiazem ER 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.