CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
colchicine tabletsdrug
Likely dose
colchicine tablets 1.2mgfrom 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/NCT01017042
NCT01017042Phase 1Completed
CompareCT.gov

Open-Label Pharmacokinetic Study of a Low-Dose Acute Gout Regimen

Mutual Pharmaceutical Company, Inc.·interventional·Posted Nov 20, 2009·Updated Nov 20, 2009

In Brief

A Phase 1 clinical trial evaluating colchicine tablets for Pharmacokinetics. Completed, enrolled 13 participants across 1 site.

Detailed Summary

This study aims to characterize the pharmacokinetic profile of colchicine after a regimen of 1.8 mg over two hours. A secondary goal is to evaluate the safety and tolerability of this regimen in healthy volunteers. To this end, all study subjects will be monitored for adverse effects throughout the entire study period.

Study Details

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

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 20, 2009
Enrollment StartSep 1, 2007
Primary CompletionSep 1, 2007
Study CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 16.6 years ago

Interventions

colchicine tabletsdrug

colchicine 1.2mg initially; then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours)