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Pharmacokinetic Study With Colchicine in Healthy Volunteers

NCT01017003 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2009-11-20

Study results available
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Summary

This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.

Conditions

  • Pharmacokinetics

Interventions

DRUG

colchicine tablets

0.6mg colchicine tablet

DRUG

colchicine tablets

0.6mg q12 hours for 10 days

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony R Godfrey, Pharm.D. · PRACS Institiute, Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2007-10-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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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 NCT01017003 on ClinicalTrials.gov