At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A One-Directional, Open-Label, Drug Interaction Study to Investigate the Effects of Multiple-Dose Colchicine on Single-Dose Pharmacokinetics of Theophylline in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Theophylline and Colchicine for Pharmacokinetics. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe substrate. When the two are co-administered the potential exists for a clinically significant drug interaction. This study aims to determine the effect of steady-state colchicine on the pharmacokinetics of theophylline administered as a single dose. A secondary goal is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the entire study period.
Study Details
Timeline
Interventions
single doses of 300 mg (80 mg/15 ml elixer) administered alone at 7:45 am on Day 1 and then along with colchicine at 7:45 am on Day 19
one 0.6 mg tablet twice daily at 7:45 am and 7:45 pm on Days 5 to 19