CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Colchicine 0.6 mg tablet +1 moredrug
Likely dose
Colchicine 0.6 mg tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01130051
NCT01130051Phase 1Completed
CompareCT.gov

A Pilot Bioavailability Study of Colcrys® Tablet 0.6 mg Versus Colcrys® Tablets 0.6 mg Crushed and Sprinkled on Applesauce Under Fasting Conditions

Mutual Pharmaceutical Company, Inc.·interventional·Posted May 25, 2010·Updated May 12, 2011

In Brief

A Phase 1 clinical trial evaluating Colchicine 0.6 mg tablet for Healthy. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2010
Enrollment StartMay 1, 2010
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.1 years ago

Interventions

Colchicine 0.6 mg tabletdrug

One Colcrys® 0.6 mg intact tablet taken by mouth

Colchicine 0.6 mg tabletdrug

One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce