drugset / Trial / NCT01130051

Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce

NCT01130051

Phase 1 Completed 16 enrolled Mutual Pharmaceutical Company, Inc.
RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1 tablespoon) relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. 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.

Timeline

Start
2010-05
Primary completion
2010-06
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.6 mg Oral

Indications

No indication recorded.