At a glance
ClinicalIndex Comparison RecordPhase 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.
A Pilot Bioavailability Study of Colcrys® Tablet 0.6 mg Versus Colcrys® Tablet 0.6 mg Crushed and Dissolved in Apple Juice Under Fasting Conditions
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 dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedMay 2010
Primary CompletionJun 2010
TodayJul 2026
First PostedMay 14, 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 dissolved in apple juice