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Drug-Drug Interaction Study of Colchicine and Azithromycin

NCT00983294 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-10-28

Study results available
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Summary

Azithromycin is a possible weak to moderate inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of azithromycin on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Colchicine

A single dose of 0.6 mg colchicine administered alone at 7:30 am on Day 1

DRUG

Azithromycin

Two 250 mg azithromycin tablets administered at 7:30 am on Day 15, then one 250 mg tablet administered daily at 7:30 am on Days 16 to 19.

DRUG

Colchicine

A single dose of 0.6 mg colchicine administered with azithromycin at 7:30 am on Day 19.

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony R Godfrey, Pharm.D. · PRACS - Cetero

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-08-31
Completion
2008-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00983294 on ClinicalTrials.gov