drugset / Trial / NCT00983905

Drug-Drug Interaction Study of Colchicine and Theophylline

NCT00983905

Phase 1 Completed 30 enrolled Mutual Pharmaceutical Company, Inc.
Non-randomizedSingle-groupOpen-labelBasic science

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.

Timeline

Start
2008-08
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.6 mg
Subject Theophylline Small molecule 300 mg

Indications

No indication recorded.