CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Colchicine +2 moredrug
Likely dose
Colchicine 0.6mgfrom 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/NCT01021020
NCT01021020Phase 1Completed
CompareCT.gov

Randomized, 3-Way Crossover Bioequivalence Study of Single Dose Colchicine Tablets and Effect of Food

Mutual Pharmaceutical Company, Inc.·interventional·Posted Nov 26, 2009·Updated Dec 9, 2009

In Brief

A Phase 1 clinical trial evaluating Colchicine and Colchicine/Probenecid for Healthy. Completed, enrolled 28 participants across 1 site.

Detailed Summary

This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting conditions. It will also determine the bioavailability following a standard high-fat meal and evaluate the safety and tolerability of the test product.

Study Details

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

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 26, 2009
Enrollment StartSep 1, 2007
Primary CompletionOct 1, 2007
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.6 years ago

Interventions

Colchicinedrug

0.6mg tablet administered after a fast of at least 10 hours

Colchicinedrug

0.6mg tablet administered after a standardized high-fat, high-calorie breakfast

Colchicine/Probeneciddrug

0.5mg/500mg tablet administered after a fast of at least 10 hours