Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to compare the pharmacokinetic profiles of colchicine
and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of
colchicine in healthy adults with normal renal function, in patients with mild, moderate or
severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An
additional objective of this study is to study the clearance of colchicine and its
metabolites by hemodialysis. Secondary objectives include evaluation of the safety and
tolerability of colchicine in the study population.